Retrospective Analysis of Renal Prognosis in Patients With Chronic Kidney Disease

NCT ID: NCT03201406

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

837 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-20

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Nephropathies Lupus Nephritis Rapidly Progressive Glomerulonephritis Chronic Kidney Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YUNG-MING CHEN, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Yung-Ming Chen

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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YUNG-MING CHEN, M.D.

Role: CONTACT

+886-2-2312-3456 ext. 65993

Facility Contacts

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YUNG-MING CHEN, M.D.

Role: primary

+886-2-2312-3456 ext. 65993

YUNG-MING CHEN, M.D.

Role: primary

+886-2-2312-3456 ext. 65993

Other Identifiers

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201612068RIND

Identifier Type: -

Identifier Source: org_study_id

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