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Retrospective Analysis of Renal Prognosis in Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03201406
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
During 1993 and 2006, a total of 987 patients older than 20 years underwent native kidney biopsy at the Renal Division of this hospital. 404 patients with membranoproliferative glomerulonephritis and mesangioproliferative glomerulonephritis, and patients with secondary glomerulonephritis or other renal pathologies, such as diabetic nephropathy, lupus nephritis, rapid progress glomerulonephritis, acute tubular necrosis, and tubulointerstitial nephritis will be analyzed. The demographic characteristics and laboratory data of these patients at presentation or before renal biopsy will be recorded. These data included parameters such as age, sex, diabetes, hypertension, immunosuppressants treatment, BUN, serum creatinine, albumin, hemoglobin, total cholesterol, triglycerides, and urine protein. All subjects will be followed until 2015 for occurrence of primary endpoints, including all-cause death or ESRD requiring long-term dialysis or renal transplantation. A total of 433 patients who had been followed for 3 years during 2003 and 2007 will receive regular clinic follow-up. GFR will be estimated according to the Modification of Diet in Renal Disease (MDRD) abbreviated formula: 186 x Scr -1.154 x age -0.203 x 0.742 (if female). CKD stage will be determined as described by the National Kidney Foundation of the United States. At the time of entry, GFRs of 30-59, 29-15 and < 15 ml/min/1.73 m2 for more than 3 months will be classified as CKD stages 3, 4 and 5, respectively. Baseline Data of the 433 patients are used as recorded at the beginning during 2003 and 2007. The observation period of each patient is defined to start immediately after the registered measurement of serum creatinine satisfying the above criteria (designated as the index date) and lasted until ESRD or end of 2015. ESRD is defined as initiation of RRT, i.e. chronic dialysis or renal transplantation.

Condition or disease
Diabetic Nephropathies Lupus Nephritis Rapidly Progressive Glomerulonephritis Chronic Kidney Diseases

Study Type : Observational
Estimated Enrollment : 837 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Renal Prognosis in Patients With Chronic Kidney Disease
Actual Study Start Date : June 20, 2017
Estimated Primary Completion Date : October 31, 2017
Estimated Study Completion Date : December 31, 2017





Primary Outcome Measures :
  1. End Stage Renal Disease [ Time Frame: 21 years ]
  2. Mortality [ Time Frame: 21 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Medical Center cases
Criteria

Inclusion Criteria :

  • Patients older than 20 years.
  • Patients underwent native kidney biopsy at the Renal Division of this hospital, and with renal pathologies, such as diabetic nephropathy, lupus nephritis, rapid progress glomerulonephritis.
  • Patients were classified as CKD stages 3A, 3B, 4 and 5 at the time of entry.

Exclusion Criteria :

  • Patients younger than 20 years.
  • Patients older than 20 years underwent native kidney biopsy at the Renal Division of this hospital, and with renal pathologies, such as membranoproliferative glomerulonephritis, mesangioproliferative glomerulonephritis, secondary glomerulonephritis, or other renal pathologies, such as, acute tubular necrosis, and tubulointerstitial nephritis.
  • Patients older than 20 years but eGFR ≧ 60 ml/min/1.73 m2 at the time of entry.

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): NCT03201406


Contacts
Contact: YUNG-MING CHEN, M.D. +886-2-2312-3456 ext 65993 chenym@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: YUNG-MING CHEN, M.D.    +886-2-2312-3456 ext 65993    chenym@ntuh.gov.tw   
Yung-Ming Chen Recruiting
Taipei, Taiwan, 100
Contact: YUNG-MING CHEN, M.D.    +886-2-2312-3456 ext 65993    chenym@ntuh.gov.tw   
Principal Investigator: YUNG-MING CHEN, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: YUNG-MING CHEN, M.D. Attending Physician, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan, ROC

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03201406     History of Changes
Other Study ID Numbers: 201612068RIND
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by National Taiwan University Hospital:
Renal biopsy, Chronic kidney disease,Diabetic nephropathy,Lupus Nephritis

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Renal Insufficiency, Chronic
Nephritis
Lupus Nephritis
Glomerulonephritis
Urologic Diseases
Renal Insufficiency
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases