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Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy

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ClinicalTrials.gov Identifier: NCT00253786
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Kenichi Shikata, Okayama University

Brief Summary:
Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Diabetic Nephropathy Other: Intensive multifactorial therapy Other: Standard therapy Not Applicable

Detailed Description:
Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study for the Effectiveness of Intensive Therapy for Diabetic Nephropathy in Unblinded, Randomized Intergroup Comparison Study.
Actual Study Start Date : May 3, 2005
Actual Primary Completion Date : November 27, 2014
Actual Study Completion Date : November 27, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensive multifactorial therapy (Protocol A)
Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female.
Other: Intensive multifactorial therapy
Blood glucose control: HbA1c < 5.8% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, muitivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care

Active Comparator: Standard therapy (Protocol A)
Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female.
Other: Standard therapy
Blood glucose control: HbA1c < 6.5% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)

Experimental: Intensive multifactorial therapy (Protocol B)
Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.
Other: Intensive multifactorial therapy
Blood glucose control: HbA1c < 5.8% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, muitivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care

Active Comparator: Standard therapy (Protocol B)
Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.
Other: Standard therapy
Blood glucose control: HbA1c < 6.5% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)




Primary Outcome Measures :
  1. Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A [ Time Frame: 5 years ]
  2. Composite endpoint of time to first occurrence of (1) Doubling of serum creatinine, (2) Need for chronic dialysis or renal transplantation, or (3) Death in Protocol B [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. GFR in Protocol A [ Time Frame: 5 years ]
  2. Cardiovascular event in Protocol A [ Time Frame: 5 years ]
  3. Progression of retinopathy in Protocol A [ Time Frame: 5 years ]
  4. Urinary albumin/creatinine ratio in Protocol A [ Time Frame: 5 years ]
  5. Proteinuria (24 h collection sample) in Protocol A [ Time Frame: 5 years ]
  6. GFR in Protocol B [ Time Frame: 5 years ]
  7. Cardiovascular event in Protocol B [ Time Frame: 5 years ]
  8. Progression of retinopathy in Protocol B [ Time Frame: 5 years ]
  9. Urinary albumin/creatinine ratio in Protocol B [ Time Frame: 5 years ]
  10. Urinary protein/creatinine ratio in Protocol B [ Time Frame: 5 years ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with type 2 diabetes
  2. Urinary albumin-to-creatinine ratio: >=300 mg/g creatinine twice in the first morning urine sample
  3. Serum creatinine level: =<2.5 mg/dl
  4. Patients aged 20-75 years

Exclusion Criteria:

  1. Type 1 diabetes
  2. Hereditary diabetes or secondary diabetes
  3. Non-diabetic nephropathy
  4. Familial hypercholesterolemia
  5. Secondary hypertension
  6. Unstable angina pectoris or history of myocardial infarction/stroke within 6 months prior to consent acquisition
  7. Malignant tumor or life threatening disease
  8. History of angioedema
  9. Patients undergoing LDL apheresis
  10. Billiary system obstruction or severe liver injury
  11. Liver dysfunction
  12. Allergy for ACE-Is, ARBs or HMG-CoA reductase inhibitors
  13. Pregnant or nursing patients
  14. Others: patients who are not suitable for this trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253786


Locations
Japan
Okayama University Hospital
Okayama, Japan, 700-8558
Sponsors and Collaborators
Okayama University
Investigators
Principal Investigator: Hirofumi Makino, M.D. Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Responsible Party: Kenichi Shikata, Professor, Okayama University
ClinicalTrials.gov Identifier: NCT00253786     History of Changes
Other Study ID Numbers: DNETT-Japan
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

Keywords provided by Kenichi Shikata, Okayama University:
diabetes
nephropathy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications