Clinical trial NCT03201406: Retrospective Analysis of Renal Prognosis in Patients With Chronic Kidney Disease
Official title: Retrospective Analysis of Renal Prognosis in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Nephropathies
Lupus Nephritis
Rapidly Progressive Glomerulonephritis
Chronic Kidney Diseases
Keywords: Renal biopsy, Chronic kidney disease,Diabetic nephropathy,Lupus Nephritis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 837
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical Center cases

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.


Eligibility 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.

Primary outcomes:
measure: End Stage Renal Disease
timeFrame: 21 years
measure: Mortality
timeFrame: 21 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Yung-Ming Chen
Study officials:
affiliation: Attending Physician, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan, ROC
name: YUNG-MING CHEN, M.D.
role: PRINCIPAL_INVESTIGATOR
References: