CClinicalTrials.gg
Status unknownNCT03201406Updated Jul 2, 2017

Retrospective Analysis of Renal Prognosis in Patients With Chronic Kidney Disease

An observational study in Diabetic Nephropathies, Lupus Nephritis and Rapidly Progressive Glomerulonephritis, sponsored by National Taiwan University Hospital. Status unknown at 2 sites in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
837
Ages
20 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Renal biopsy, Chronic kidney disease,Diabetic nephropathy,Lupus Nephritis
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 837 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Medical Center cases

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
837 participants (estimated)
06

What researchers measure

Primary outcomes

  1. End Stage Renal Disease

    Time frame: 21 years

  2. Mortality

    Time frame: 21 years

07

Study locations

2 of 2 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
  • Yung-Ming Chen
    Taipei, 100, Taiwan
    • YUNG-MING CHEN, M.D. · Contact · chenym@ntuh.gov.tw · +886-2-2312-3456
    • YUNG-MING CHEN, M.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03201406
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jun 28, 2017
Start date
Jun 20, 2017
Primary completion
Oct 31, 2017 (estimated)
Completion
Dec 31, 2017 (estimated)
Last update
Jul 2, 2017

Study contacts

YUNG-MING CHEN, M.D.
Contact
chenym@ntuh.gov.tw
+886-2-2312-3456 ext. 65993
YUNG-MING CHEN, M.D.
principal investigator · Attending Physician, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan, ROC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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