| 1 |
NCT02517320 |
Completed |
Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy |
|
- Drug: MT-3995 Low
- Drug: MT-3995 Middle
- Drug: MT-3995 High
- Drug: Placebo
|
Interventional |
Phase 2 |
- Mitsubishi Tanabe Pharma Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change form baseline in UACR
- Change in UACR classification
- Change in renal function
- (and 2 more...)
|
293 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT02517320 |
MT-3995-J05 |
|
July 2015 |
November 2016 |
January 2017 |
August 7, 2015 |
March 3, 2017 |
|
- Investigational site
Hokkaido, Japan
|
|
| 2 |
NCT02205372 |
Completed |
Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy |
|
- Drug: MT-3995
- Drug: Placebo
|
Interventional |
Phase 1
Phase 2 |
- Mitsubishi Tanabe Pharma Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Frequency and nature of treatment-emergent adverse events and serious adverse events.
- Plasma concentrations of MT-3995
- Plasma concentrations of major metabolite of MT-3995
- (and 2 more...)
|
31 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT02205372 |
MT-3995-J04 |
|
July 2014 |
August 2015 |
August 2015 |
July 31, 2014 |
September 16, 2015 |
|
- Touei Hospital
Sapporo, Hokkaido, Japan
|
|
| 3 |
NCT02204280 |
Completed |
The Significance of Urine UbA52 In the Diagnosis of Diabetic Nephropathy |
|
|
Observational |
|
- Hebei Medical University Third Hospital
- Sixth Affiliated Hospital, Sun Yat-sen University
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- The urine UbA52 levels in 30 patients with type 2 diabetic mellitus,30 patients with diabetic nephropathy，30 patients with proteinuria due to nondiabetic renal disease and 30 healthy persons
|
120 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02204280 |
HebeiMUTH |
|
August 2014 |
July 2015 |
July 2015 |
July 30, 2014 |
July 21, 2015 |
|
|
|
| 4 |
NCT01889277 |
Completed |
Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy |
|
- Drug: MT-3995-Low
- Drug: MT-3995-High
- Drug: Placebo
|
Interventional |
Phase 1
Phase 2 |
- Mitsubishi Tanabe Pharma Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Frequency and nature of treatment-emergent adverse events and serious adverse events.
- Plasma concentrations of MT-3995 and its major metabolite
- Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure
|
51 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT01889277 |
MT-3995-J03 |
|
July 2013 |
January 2015 |
January 2015 |
June 28, 2013 |
January 27, 2015 |
|
- Koukan Hospital
Kawasaki, Kanagawa Pref., Japan
|
|
| 5 |
NCT03436693 |
Recruiting |
Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy |
|
- Drug: Canagliflozin
- Drug: Placebo
|
Interventional |
Phase 3 |
- Mitsubishi Tanabe Pharma Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The proportion of subjects with a decline in estimated glomerular filtration rate (eGFR) from baseline at Week 104
- Change from baseline in eGFR at each assessment time point
- Time to the first occurrence of an event in the composite endpoint: end-stage renal disease (ESRD), doubling of serum creatinine, renal death, or cardiovascular (CV) death
- Change from baseline in urine albumin-to-creatinine ratio (UACR) at each assessment time point
|
300 |
All |
30 Years and older (Adult, Senior) |
NCT03436693 |
TA-7284-14 |
|
February 15, 2018 |
September 2021 |
September 2021 |
February 16, 2018 |
April 5, 2018 |
|
- Research site
Aichi, Japan - Research site
Chiba, Japan - Research site
Fukuoka, Japan - (and 23 more...)
|
|
| 6 |
NCT02704494 |
Completed |
Resveratrol's Effects in Diabetic Nephropathy |
|
- Drug: Resveratrol
- Drug: Placebo
- Drug: Losartan
|
Interventional |
Early Phase 1 |
- Shiraz University of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Urine albumin level
- Serum creatinin
- Fasting blood sugar (FBS)
- (and 4 more...)
|
60 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02704494 |
93-01-49-9028 |
ReDNeph |
March 2016 |
February 2017 |
February 2017 |
March 10, 2016 |
October 5, 2017 |
|
- Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
|
|
| 7 |
NCT03407989 |
Recruiting |
SWIDINEP a Swiss Diabetic Nephropathy Cohort |
|
|
Observational |
|
- Centre Hospitalier Universitaire Vaudois
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- estimated GFR decline ml/min/y
- 24 hour blood pressure measurements (mmHg) and eGFR decline (ml/min/y)
- Vascular markers (Pulse wave velocity (m/s); Carotid and radial augmentation indexes (%); intima media thickness (mm)) and eGFR decline (ml/min/y)
- (and 6 more...)
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT03407989 |
CER 43/12 |
SWIDINEP |
January 1, 2014 |
January 1, 2022 |
January 1, 2022 |
January 23, 2018 |
January 24, 2018 |
|
- Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland
|
|
| 8 |
NCT03147677 |
Recruiting |
Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and Irbesartan |
- Type 2 Diabetic Nephropathy
|
- Drug: Alfacalcidol
- Drug: Irbesartan
|
Interventional |
Phase 4 |
- The Third Xiangya Hospital of Central South University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes in 24h urinary albumin excretion rate (UAER) by comparing visits at week 20 with the baseline
- Changes in 24h urinary protein quantity by comparing visits at week 20 with the baseline
- Changes in estimated glomerular filtration rate (eGFR) by comparing visits at week 20 with the baseline
- (and 3 more...)
|
216 |
All |
18 Years to 65 Years (Adult) |
NCT03147677 |
320.6750.16025 |
|
July 2016 |
July 2018 |
December 2018 |
May 10, 2017 |
October 25, 2017 |
|
- The Third Xiangya Hospital of Central South University
Changsha, Hunan, China - Hunan Chenzhou NO.1 People's Hospital
Chenzhou, Hunan, China - Hunan Yiyang Central Hospital
Yiyang, Hunan, China
|
|
| 9 |
NCT01756703 |
Completed |
A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria |
|
- Drug: MT-3995 Low
- Drug: MT-3995 High
- Drug: Placebo
|
Interventional |
Phase 2 |
- Mitsubishi Tanabe Pharma Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
- Frequency and nature of treatment-emergent adverse events and serious adverse events.
- Percentage change from baseline in UACR compared to placebo
- (and 2 more...)
|
67 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01756703 |
MT-3995-E06 |
|
November 2012 |
August 2014 |
August 2014 |
December 27, 2012 |
February 9, 2015 |
|
- Investigational site
Blagoevgrad, Bulgaria - Investigational site
Burgas, Bulgaria - Investigational site
Byala, Bulgaria - (and 40 more...)
|
|
| 10 |
NCT01756716 |
Completed |
A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria and Moderately Decreased GFR |
|
- Drug: MT-3995 Low
- Drug: MT-3995 High
- Drug: Placebo
|
Interventional |
Phase 2 |
- Mitsubishi Tanabe Pharma Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
- Frequency and nature of treatment-emergent adverse events and serious adverse events.
- Percentage change from baseline in UACR compared to placebo
- (and 2 more...)
|
49 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01756716 |
MT-3995-E07 |
|
December 2012 |
September 2014 |
September 2014 |
December 27, 2012 |
February 9, 2015 |
|
- Investigational site
Blagoevgrad, Bulgaria - Investigational site
Pazardzhik, Bulgaria - Investigational site
Pleven, Bulgaria - (and 47 more...)
|
|
| 11 |
NCT03288571 |
Not yet recruiting |
Use of Wharton Jelly in Diabetic Nephropathy |
|
- Biological: Wharton Jelly Mesenchymal stem cells
|
Interventional |
Phase 1
Phase 2 |
- Sophia Al-Adwan
- Jordan University of Science and Technology
- An-Najah National University
- University of Jordan
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Evaluation of the preliminary efficacy of the injection on kidney's Estimated Glomerular filtration rate
- Evaluation of the preliminary efficacy of the injection on kidney's protein to creatinine ratio
|
20 |
All |
35 Years to 70 Years (Adult, Senior) |
NCT03288571 |
DNJUCTC |
|
January 2018 |
December 2018 |
April 2019 |
September 20, 2017 |
September 20, 2017 |
|
|
|
| 12 |
NCT02442921 |
Recruiting |
Colchicine for Diabetic Nephropathy Trial |
|
- Drug: Colchicine
- Drug: Placebo
|
Interventional |
Phase 1
Phase 2 |
- Sheba Medical Center
- D-Cure, Israel
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change of urinary protein excretion ( mg/24hrs) from baseline to 18 months.
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02442921 |
SHEBA-2015-1560-SK-CTIL |
CDNT |
February 22, 2016 |
April 30, 2019 |
April 30, 2019 |
May 13, 2015 |
May 9, 2017 |
|
- Sheba Medical Center
Ramat Gan, Israel
|
|
| 13 |
NCT03174821 |
Completed |
Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy |
- Insulin Pump Therapy in Treating Diabetic Nephropathy
|
|
Interventional |
Not Applicable |
- Chinese PLA General Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The change of 8-hydroxy-deoxyguanosine (8-OHdG)
- The change of 3-nitrotyrosine (3-NT)
- The change of glutathione (GSH)
- The change of superoxide dismutase (SOD)
|
160 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03174821 |
IPT-OX-10 |
|
October 20, 2010 |
May 16, 2014 |
May 16, 2014 |
June 5, 2017 |
June 5, 2017 |
|
|
|
| 14 |
NCT02690883 |
Unknown † |
Effect of Exenatide on 24h-UAER in Patients With Diabetic Nephropathy |
|
- Drug: Exenatide
- Drug: Lispro
|
Interventional |
Phase 4 |
- Nanfang Hospital of Southern Medical University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- the percentage change of 24h-UAER(urinary albumin excretion rates) from baseline at Week 24
|
90 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02690883 |
ESR-14-10425 |
|
March 2016 |
March 2017 |
October 2017 |
February 24, 2016 |
February 24, 2016 |
|
|
|
| 15 |
NCT00317954 |
Completed |
Spironolactone in Diabetic Nephropathy |
|
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Changes in albuminuria
- Changes in blood pressure
- Changes in glomerular filtration rate
|
48 |
All |
18 Years and older (Adult, Senior) |
NCT00317954 |
2612-2233 |
|
September 2003 |
|
July 2005 |
April 25, 2006 |
April 25, 2006 |
|
- Steno Diabetes Center
Gentofte, Denmark
|
|
| 16 |
NCT02768948 |
Not yet recruiting |
Telmisartan Promotes the Differentiation of Monocytes Into Macrophages M2 in Diabetic Nephropathy? |
|
- Drug: telmisartan during 6 months
- Drug: Losartan during 6 months
- Procedure: blood sample
|
Interventional |
Not Applicable |
- Centre Hospitalier Universitaire de Nice
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- number of differentiation marker
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT02768948 |
16-AOI-09 |
|
July 2016 |
July 2018 |
July 2018 |
May 11, 2016 |
May 12, 2016 |
|
|
|
| 17 |
NCT00708981 |
Completed |
Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN) |
|
- Other: Multifactorial Intervention
|
Interventional |
Phase 4 |
- John H. Stroger Hospital
- Sanofi
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4)
|
120 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00708981 |
Metabolism IST
IRB# 06-177 |
|
May 2007 |
October 2013 |
December 2013 |
July 3, 2008 |
October 2, 2014 |
|
- John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
|
|
| 18 |
NCT01005121 |
Unknown † |
Colchicine for Diabetic Nephropathy |
|
|
Interventional |
Phase 2 |
- Prof.Avi Livneh
- Sheba Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 24 hr urine protein collection
|
12 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT01005121 |
SHEBA-09-7369-AL-CTIL |
|
December 2009 |
December 2014 |
December 2015 |
October 30, 2009 |
January 4, 2013 |
|
- Sheba medical center, Tel hashomer
Ramat gan, Israel
|
|
| 19 |
NCT00782847 |
Completed |
Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy |
|
- Behavioral: DiaNe consultation and support program
|
Interventional |
Phase 3 |
- DiaNe HCM GmbH
- Roche Pharma Deutschland GmbH, Grenzach-Wyhlen, Germany
- Institute for Medical Outcom Research GmbH, Loerrach, Germany
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- deterioration of kidney function in diabetic nephropathy
- HbA1c
|
125 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00782847 |
DiaNe-Studie |
DiaNe |
July 2004 |
January 2007 |
January 2007 |
October 31, 2008 |
October 31, 2008 |
|
- Diabetes- und Nierenzentrum Dormagen
Dormagen, NRW, Germany
|
|
| 20 |
NCT01779089 |
Unknown † |
Minocycline and Proteinuria in Diabetic Nephropathy |
|
- Drug: Minocycline 100 mg po bid for 6 months
- Drug: placebo
|
Interventional |
Not Applicable |
- Los Angeles Biomedical Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in 24 hour urine protein/creatinine ratio (average of 2 values) baseline compared to 6-months in placebo vs minocycline
- Change in average MACR in 24 hour urine, daytime and overnight collections (baseline vs 6 mos)
- Change in average 24 hour urine protein/creatinine in daytime vs overnight collections, baseline vs 6 mos
- Change in urine and blood biomarkers in minocycline vs placebo treated patients at baseline vs 6 mos
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT01779089 |
013400 |
|
February 2009 |
March 2016 |
March 2016 |
January 30, 2013 |
May 21, 2015 |
|
- Los Angeles Biomedical Reaearch Institute at Harbor-UCLA Medical Center
Torrance, California, United States
|
|
| 21 |
NCT02488252 |
Recruiting |
Semi-individualised Chinese Medicine Treatment as an Adjuvant Management for Diabetic Nephropathy |
|
- Drug: Semi-individualised Chinese Medicine treatment
- Drug: Routine medical care (active comparator)
|
Interventional |
Phase 2
Phase 3 |
- The University of Hong Kong
- School of Chinese Medicine, The University of Hong Kong
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in estimated GFR
- Change in spot urine albumin-to-creatinine ratio
- Change in fasting blood glucose (FBG)
- (and 11 more...)
|
148 |
All |
35 Years to 80 Years (Adult, Senior) |
NCT02488252 |
DN-CM-1 |
SCHEMATIC |
July 2015 |
June 2019 |
December 2019 |
July 2, 2015 |
May 17, 2018 |
|
- Queen Mary Hospital
Hong Kong, Hong Kong
|
|
| 22 |
NCT01003236 |
Completed |
Evaluating the Renoprotective Effect of Milk Thistle Extract on Patients With Type II Diabetic Nephropathy |
|
- Drug: placebo
- Drug: Milk Thistle extract
|
Interventional |
Phase 2 |
- Shiraz University of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in urinary albumin-creatinine ratio
- Change from baseline in urinary TNF-α
- Change from baseline in urinary TGF-β
- (and 9 more...)
|
60 |
All |
30 Years to 70 Years (Adult, Senior) |
NCT01003236 |
4774 |
|
October 2010 |
October 2011 |
November 2011 |
October 28, 2009 |
June 25, 2012 |
|
- Motahari Clinic
Shiraz, Fars, Iran, Islamic Republic of
|
|
| 23 |
NCT01858532 |
Terminated |
Study Of Diabetic Nephropathy With Atrasentan |
|
- Drug: Atrasentan
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to the first occurrence of a component of the composite renal endpoint.
- Time to first occurrence of a component of composite renal endpoint: confirmed doubling of serum creatinine or the onset of end stage renal disease for all randomized subjects (pooled).
- Time to a 50% estimated glomerular filtration rate reduction.
- (and 2 more...)
|
5112 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT01858532 |
M11-352
2012-005848-21 |
SONAR |
May 17, 2013 |
March 29, 2018 |
March 29, 2018 |
May 21, 2013 |
April 26, 2018 |
|
- Nephrology Associates P.C.
Birmingham, Alabama, United States - University of Alabama
Birmingham, Alabama, United States - Nephrology Consultants, LLC
Huntsville, Alabama, United States - (and 793 more...)
|
|
| 24 |
NCT02410499 |
Withdrawn |
Efficacy and Safety of Weekly Subcutaneous MLN1202 in Improving Diabetic Nephropathy in Participants With Macroalbuminuria |
|
- Drug: MLN1202 Placebo
- Drug: MLN1202
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Day 85
- Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Over Time
- Change from Baseline in Urinary Protein:Creatinine Ratio (UPCR) Over Time
|
0 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT02410499 |
MLN1202-2005
2014-005142-21
U1111-1168-1426 |
|
May 20, 2015 |
November 17, 2015 |
November 17, 2015 |
April 7, 2015 |
September 25, 2017 |
|
|
|
| 25 |
NCT00967629 |
Completed |
Effect of Sevelamer Carbonate on Oxidative Stress in Patients With Diabetic Nephropathy |
|
- Drug: Sevelamer Carbonate
- Drug: Calcium Carbonate
|
Interventional |
Phase 1 |
- Icahn School of Medicine at Mount Sinai
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- serum AGE levels
- inflammatory markers
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT00967629 |
GCO 08-0976 |
|
June 2009 |
February 2010 |
February 2010 |
August 28, 2009 |
November 18, 2011 |
|
- Mount Sinai School of Medicine
New York, New York, United States
|
|
| 26 |
NCT01774981 |
Completed
Has Results |
Study of LY3016859 in Participants With Diabetic Nephropathy |
|
- Drug: Placebo
- Drug: LY3016859
|
Interventional |
Phase 1
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Part B:Change From Baseline in Proteinuria
- Part A and Part B: Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs
- Part B: Change From Baseline in Proteinuria Over Time
- Part B: Change From Baseline in Albuminuria Over Time
|
60 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01774981 |
14353
I5V-MC-TGAB
2012-004496-40 |
|
March 2013 |
August 2015 |
August 2015 |
January 24, 2013 |
October 6, 2017 |
August 15, 2017 |
- Innovative Research of West Florida
Clearwater, Florida, United States - Creighton University Medical Center
Omaha, Nebraska, United States - Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States - (and 4 more...)
|
|
| 27 |
NCT00130312 |
Terminated |
Effect of Sulodexide in Overt Diabetic Nephropathy |
|
|
Interventional |
Phase 4 |
- Keryx Biopharmaceuticals
- Collaborative Study Group (CSG)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to doubling of the serum creatinine or end stage kidney disease (ESRD)
- Safety and tolerance of sulodexide therapy long-term
- Change in urinary protein/albumin excretion
|
1248 |
All |
18 Years and older (Adult, Senior) |
NCT00130312 |
KRX-101-401 |
|
August 2005 |
March 2008 |
March 2008 |
August 15, 2005 |
May 5, 2015 |
|
- The Collaborative Study Group, Clinical Coordinating Center for U.S. and Canadian clinics, Rush University Medical Center
Chicago, Illinois, United States - The Collaborative Study Group, Clinical Coordinating Center for the Pacific Region, Monash Medical Center
Clayton / Melbourne, Victoria, Australia - The Collaborative Study Group, Clinical Coordinating Center for European Clinics, University of Groningen
Groningen, Netherlands
|
|
| 28 |
NCT01796418 |
Unknown † |
Beraprost Sodium and Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy |
|
|
Interventional |
Not Applicable |
- Seoul National University Hospital
- Astellas Pharma Korea, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Brachial ankle pulse wave velocity (PWV)
- Ankle brachial indices (ABI)
- Urine albumin creatinine ratio (UACR)
- (and 3 more...)
|
102 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT01796418 |
BESTinDN-001 |
|
March 2013 |
August 2014 |
|
February 21, 2013 |
December 16, 2013 |
|
- Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of - Seoul National University Bundang Hospital
Seongnam, Korea, Republic of - Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of - (and 2 more...)
|
|
| 29 |
NCT01935167 |
Completed |
To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy |
|
- Drug: DW1029M 600mg
- Drug: DW1029M 1200mg
- Drug: Placebo
|
Interventional |
Phase 2 |
- Dong Wha Pharmaceutical Co. Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- log ACR
- Log UAE
- eGFR
- (and 2 more...)
|
158 |
All |
30 Years and older (Adult, Senior) |
NCT01935167 |
DW1029M |
|
October 2013 |
August 2014 |
February 2015 |
September 4, 2013 |
February 17, 2017 |
|
- DongWha Pharm
Seoul, Korea, Republic of
|
|
| 30 |
NCT01068041 |
Completed |
Effects of PH3 in Diabetic Nephropathy |
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Urinary Albumin/Creatinine Ratio (UACR)
- Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c
|
100 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01068041 |
PH-CP016 |
PH3 |
August 2010 |
July 2014 |
September 2015 |
February 12, 2010 |
November 4, 2015 |
|
- Taichung Veterans General Hospital
Taichung, Taiwan - Tri-Service General Hospital
Taipei, Taiwan - Taipei Veterans General Hospital
Taipei, Taiwan
|
|
| 31 |
NCT00870402 |
Unknown † |
Aldosterone in Diabetic Nephropathy |
|
- Drug: Spironolactone
- Drug: Placebo
|
Interventional |
Phase 4 |
- Universidad Los Andes, Chile
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Reduction of albuminuria
- Reduction of diastolic disfunction
|
160 |
All |
30 Years to 70 Years (Adult, Senior) |
NCT00870402 |
SA08I20032 |
ALDODN |
March 2009 |
December 2009 |
March 2010 |
March 27, 2009 |
March 27, 2009 |
|
- University of Los Andes
Santiago, Chile
|
|
| 32 |
NCT01768611 |
Completed |
SLC2A1 Variants and Diabetic Nephropathy |
|
|
Observational |
|
- University of Sao Paulo General Hospital
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
|
449 |
All |
11 Years and older (Child, Adult, Senior) |
NCT01768611 |
FMUSP-LIM25-001 |
|
October 2004 |
October 2012 |
October 2012 |
January 15, 2013 |
January 16, 2013 |
|
- Faculdade de Medicina da USP
São Paulo, SP, Brazil
|
|
| 33 |
NCT01273675 |
Unknown † |
An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy |
|
|
Observational |
|
- National Taiwan University Hospital
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
100 |
All |
30 Years to 75 Years (Adult, Senior) |
NCT01273675 |
201008056R |
|
September 2010 |
|
|
January 10, 2011 |
January 10, 2011 |
|
|
|
| 34 |
NCT00320060 |
Completed |
Effect of Pyridorin in Patients With Diabetic Nephropathy |
|
- Drug: Pyridorin (pyridoxamine dihydrochloride)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
128 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00320060 |
PYR-206 |
|
October 2001 |
|
January 2003 |
April 27, 2006 |
April 27, 2006 |
|
|
|
| 35 |
NCT00320021 |
Completed |
Effect of Pyridorin in Patients With Diabetic Nephropathy |
|
- Drug: Pyridorin (pyridoxamine dihydrochloride)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Change in Serum Creatinine from baseline to week 26
|
80 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00320021 |
PYR-205/207
PYR-205
PYR-207 |
|
July 2002 |
|
September 2003 |
April 27, 2006 |
April 27, 2006 |
|
|
|
| 36 |
NCT01601236 |
Completed
Has Results |
Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients |
|
- Drug: Repository Corticotropin Injection
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12
- Percent Change in eGFR at Visit 17
- Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death
- (and 7 more...)
|
34 |
All |
18 Years and older (Adult, Senior) |
NCT01601236 |
QSC01-DN-01 |
|
May 2012 |
January 2016 |
March 2016 |
May 17, 2012 |
August 21, 2017 |
July 24, 2017 |
- Questcor Investigational Site
Roseville, California, United States - Questcor Investigational Site
Cooper City, Florida, United States - Questcor Investigational Site
Miami Springs, Florida, United States - (and 7 more...)
|
|
| 37 |
NCT00565318 |
Completed |
Benfotiamine in Diabetic Nephropathy |
|
- Drug: Benfotiamine
- Drug: Placebo
|
Interventional |
Phase 4 |
- University Medical Center Groningen
- Isala
- Wörwag Pharma GmbH & Co. KG
- Predictions Network
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in urinary excretion of: - Kidney injury molecule-1 (KIM-1) - Albumin
- Change in urinary excretion of: β2 microglobulin, macrophage inhibiting factor (MIF), monocyte chemo-attractant protein-1 (MCP-1), and other advanced glycation end-products (AGEs).
|
86 |
All |
40 Years to 75 Years (Adult, Senior) |
NCT00565318 |
BENFO-1
NL17390.075.07 |
Benfo |
December 2007 |
June 2009 |
June 2009 |
November 29, 2007 |
November 16, 2009 |
|
- Isala Klinieken Hospital
Zwolle, Netherlands
|
|
| 38 |
NCT01163591 |
Completed |
To Assess the Accuracy of the eZscan Study in the Screening for Diabetic Nephropathy |
|
|
Observational |
|
- Chinese University of Hong Kong
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- The optimal eZscan unit to detect the presence of diabetic nephropathy as defined by eGFR and ACR using ROC analysis, sensitivity and specificity values.
- A prediction algorithm using age, sex, body mass index and eZcan score will be developed to predict eGFR as continuous and categorical variables using Cox regression analysis.
|
100 |
All |
21 Years to 75 Years (Adult, Senior) |
NCT01163591 |
CRE-2008.470-T |
|
January 2009 |
October 2009 |
October 2009 |
July 16, 2010 |
October 12, 2015 |
|
- Diabetes Mellitus and Endocrine Centre, Prince of Wales Hospital
Shatin, Hong Kong, China
|
|
| 39 |
NCT01109212 |
Completed |
The Effects of Bindarit in Diabetic Nephropathy |
|
- Drug: Bindarit
- Drug: Placebo
|
Interventional |
Phase 2 |
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Mario Negri Institute for Pharmacological Research
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen.
- Urinary Monocyte Chemoattractant protein (MCP-1/CCL2)(pg/ml) levels in the overnight urine specimen.
- Serum lipids
- (and 2 more...)
|
100 |
All |
30 Years to 70 Years (Adult, Senior) |
NCT01109212 |
004SC06084
2006-006191-38 |
|
March 2007 |
November 2008 |
December 2008 |
April 23, 2010 |
March 30, 2016 |
|
- The Mario Negri Institute for Pharmacological Research- Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy - Azienda Ospedaliera di Treviglio-Caravaggio - Unità Operativa Malattie Metaboliche e Diabetologia
Treviglio, Bergamo, Italy - Azienda Ospedaliera OO.RR. Bergamo - Unità Operativa Diabetologia
Bergamo, Italy - (and 3 more...)
|
|
| 40 |
NCT01252056 |
Completed |
A Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol in Combination on Patients With Diabetic Nephropathy |
|
- Drug: Probucol
- Drug: Probucol and Cilostazol
|
Interventional |
Phase 4 |
- Otsuka Beijing Research Institute
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- nephropathy development
- IMT
- Atherosclerosis related biomarkers
- (and 2 more...)
|
353 |
All |
40 Years to 75 Years (Adult, Senior) |
NCT01252056 |
260-09-805-01 |
|
March 2010 |
December 2012 |
December 2012 |
December 2, 2010 |
May 8, 2013 |
|
- Beijing Universuty First Hospital
Beijng, Beijing, China
|
|
| 41 |
NCT00774904 |
Completed |
Adiponectin and Insulin Resistance in Diabetic Nephropathy |
|
|
Interventional |
Not Applicable |
- Health Science Center of Xi’an Jiaotong University
- Shanghai Jiao Tong University School of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- GFR, HbA1c and the adiponectin concentration
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT00774904 |
ADPN |
|
April 2007 |
October 2007 |
November 2007 |
October 17, 2008 |
October 20, 2008 |
|
- Shanghai No.3 people's hospital
Shanghai, China
|
|
| 42 |
NCT02327754 |
Completed |
Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout |
|
- Drug: Topiroxostat BID, (Oral daily dosing for 28 weeks)
- Drug: Placebo BID, (Oral daily dosing for 28 weeks)
|
Interventional |
Phase 2 |
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Fuji Yakuhin Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in urine albumin creatinine ratio
- sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC
|
60 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT02327754 |
FY1004 |
UPWARD |
|
December 2016 |
December 2016 |
December 30, 2014 |
April 12, 2017 |
|
- Sanwa Kagaku Kenkyusho Co., Ltd.
Nagoya, Aichi, Japan
|
|
| 43 |
NCT01968668 |
Completed |
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan) |
|
- Drug: BAY94-8862
- Drug: Placebo
- Drug: BAY 94-8862
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change of urinary albumin-to creatinine ratio
- Change in serum potassium concentration
|
96 |
All |
18 Years and older (Adult, Senior) |
NCT01968668 |
16816 |
|
October 2013 |
October 2014 |
November 2014 |
October 24, 2013 |
January 9, 2015 |
|
- Nagoya, Aichi, Japan
- Nagoya, Aichi, Japan
- Saijo, Ehime, Japan
- (and 13 more...)
|
|
| 44 |
NCT00340678 |
Completed
Has Results |
Renoprotection in Early Diabetic Nephropathy in Pima Indians |
|
- Drug: Losartan
- Drug: Placebo
|
Interventional |
Phase 3 |
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants With Decline in GFR
- Glomerular Volume
|
170 |
All |
18 Years to 65 Years (Adult) |
NCT00340678 |
999995037
OH95-DK-N037 |
|
August 1995 |
May 2012 |
March 2014 |
June 21, 2006 |
July 24, 2014 |
November 19, 2013 |
- NIDDK, Phoenix
Phoenix, Arizona, United States
|
|
| 45 |
NCT02676401 |
Completed |
An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy |
|
- Drug: MT-3995 Low
- Drug: MT-3995 Middle
- Drug: MT-3995 High
|
Interventional |
Phase 2 |
- Mitsubishi Tanabe Pharma Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse events
- Change from baseline in Urine Albumin to Creatinine Ratio (UACR)
|
241 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT02676401 |
MT-3995-J06 |
|
February 2016 |
August 2017 |
|
February 8, 2016 |
September 18, 2017 |
|
- Touei Hospital
Hokkaido, Japan
|
|
| 46 |
NCT03284996 |
Not yet recruiting |
Doppler Ultrasound in Early Detection of Diabetic Nephropathy Type 2 Diabetes Mellitus. |
|
- Device: Doppler ultrasonography
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography
|
80 |
All |
25 Years to 65 Years (Adult) |
NCT03284996 |
DUDN |
|
October 1, 2017 |
April 30, 2019 |
September 1, 2019 |
September 15, 2017 |
September 15, 2017 |
|
|
|
| 47 |
NCT00353600 |
Completed |
Delaying the Progression of Diabetic Nephropathy in Pima Indians |
|
|
Observational |
|
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
25 |
All |
18 Years to 65 Years (Adult) |
NCT00353600 |
999994034
OH94-DK-N034 |
|
August 19, 1994 |
|
August 16, 2011 |
July 18, 2006 |
July 2, 2017 |
|
- NIDDK, Phoenix
Phoenix, Arizona, United States
|
|
| 48 |
NCT00664027 |
Completed |
Phase IIa Trial to Determine the Effects of Bardoxolone Methyl on Renal Function in Patients With Diabetic Nephropathy |
|
- Drug: RTA 402 (Bardoxolone Methyl)
|
Interventional |
Phase 2 |
- Reata Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the effects of RTA 402 administered orally at three dose strengths on the glomerular filtration rate (as estimated by the MDRD formula) in patients with diabetic nephropathy (stratum 1).
- To determine the effects of RTA 402 on glomerular filtration rate (as estimated by the MDRD formula) when administered for 28 days at dose of 25 mg followed by a dose of 75 mg for another 28 days in patients with diabetic nephropathy (stratum 2).
- To evaluate the safety and tolerability of oral RTA 402 administered orally at three dose strengths in patients with diabetic nephropathy.
- (and 4 more...)
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT00664027 |
RTA 402-C-0801 |
|
April 2008 |
May 2009 |
|
April 22, 2008 |
December 3, 2012 |
|
- West Houston Clinical Research Services
Houston, Texas, United States - Renal Associates, PA
San Antonio, Texas, United States - DGD Research
San Antonio, Texas, United States
|
|
| 49 |
NCT03165240 |
Recruiting |
This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 4 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated |
|
- Drug: BI 690517
- Drug: Eplerenone
- Drug: Placebo
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of patients with drug related Adverse Events (AEs)
- Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) measured in morning void urine
- Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) measured in daytime (10-hour) urine
|
105 |
All |
18 Years and older (Adult, Senior) |
NCT03165240 |
1378-0008
2017-000563-32 |
|
October 5, 2017 |
June 30, 2019 |
June 30, 2019 |
May 24, 2017 |
May 22, 2018 |
|
- Steno Diabetes Center Copenhagen
Gentofte, Denmark - Kolding Sygehus
Kolding, Denmark - Bispebjerg Hospital
København NV, Denmark - (and 18 more...)
|
|
| 50 |
NCT00136188 |
Completed |
Nitric Oxide (NO) Activity and Diabetic Nephropathy |
|
|
Interventional |
Phase 2
Phase 3 |
- University of Erlangen-Nürnberg Medical School
|
Other |
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in renal endothelial function
|
100 |
All |
18 Years to 65 Years (Adult) |
NCT00136188 |
SFB 423 TP B5 |
|
August 2009 |
December 2011 |
December 2011 |
August 26, 2005 |
June 19, 2012 |
|
- CRC, Medizinische Klnik 4 - Nephrology and Hypertension, Uni Erlangen-Nürnberg
Erlangen, Germany
|
|
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