Indian chronic kidney disease (ICKD) study: A prospective, observational cohort study in Indian patients with CKD of moderate severity

Conditions: Cardiovascular disease
N18.9
I51.6
Chronic kidney disease, unspecified
Cardiovascular disease, unspecified

Registration Number: DRKS00003701

Lead Sponsor: Department of Nephrology and Medical Intensive Care, Charité Campus Virchow-Klinikum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 5000

Inclusion Criteria

Willing patients with approximately 50% reduction in kidney function (estimated GFR 30-60 ml/min) and/or proteinuria >500 mg/g creatinine or albuminuria >300mg/g creatinine. All patients who fulfill these criteria during the recruitment phase will be informed about the study and requested to sign the consent form. Those patients who provide a written informed consent will be in recruited in the study and followed for a minimum of five years. Any medication therapy is possible and does not affect the inclusion in the ICKD study.

Exclusion Criteria

Patients with any organ or bone marrow transplantation; or patients who have received chemotherapy because of any active malignant disease within two years prior to recruitment, or patients with NYHA class III or IV heart failure at baseline, or patients with non-Indian origin will be excluded.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary renal endpoints include:<br>1) Requirement of renal replacement therapy (dialysis or transplant)<br>2) Persistent decline of GFR of at least 50% compared to baseline<br><br>The primary cardiovascular endpoints include:<br>1) Non-lethal myocardial infarction (symptomatic or silent) <br>2) Non-lethal stroke<br>3) Intervention for peripheral arterial occlusion disease <br>4) Cardiovascular conditioned death (including sudden cardiac death)<br>5) Hospitalization caused for cardiovascular reason<br><br>These endpoints will be recorded at each annual follow-up visit and in-between telephonic interviews during the entire five-year study period. The endpoints will be captured by direct interviews with the patients, hospital discharge summaries, doctor's letters and blood tests.<br>

Secondary Outcome Measures