Retrospective Analysis of Renal Prognosis in Patients With Chronic Kidney Disease

NCT03201406 | Unknown

• 1 other identifier: 201612068RIND
• Study Type: observational
• Target: 837
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Nephropathies; Lupus Nephritis; Rapidly Progressive Glomerulonephritis; Chronic Kidney Diseases

Keywords

Renal biopsy, Chronic kidney disease,Diabetic nephropathy,Lupus Nephritis

Outcome Measures

Primary Outcomes (2)

• End Stage Renal Disease

  21 years

• Mortality

  21 years

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical Center cases

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Yung-Ming Chen

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies; Lupus Nephritis; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glomerulonephritis; Nephritis; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• YUNG-MING CHEN, M.D.

  Attending Physician, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan, ROC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YUNG-MING CHEN, M.D.

CONTACT

+886-2-2312-3456; chenym@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: June 20, 2017
• Primary Completion: October 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

TW (2)