Global Kidney Patient Trials Network (GKPTN)

The George Institute

Status: Completed

Conditions: Kidney Diseases

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04389827

GKPTN2019

Details and patient eligibility

About

This is a prospective international multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease

Enrollment: 5,999 patients

Sex: All

Ages: 2 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Documented diagnosis of primary kidney disease

2. Regular visits (6-12 monthly) with a physician at a participating site that includes the monitoring of protein in urine and kidney function

3. eGFR > 25 ml/min/1.73m2

4. ≥ 2 to ≥ 80 years of age

5. One of the following laboratory urine parameters within 12 months of screening meeting the values of:

   • Urine Albumin-to-Creatinine Ratio (UACR) > 200 mg/g OR
   • Protein-to-Creatinine Ratio (PCR) > 300 mg/g OR
   • Albumin Excretion Rate (AER) > 200 mg/day OR
   • 24 hour Albumin Excretion > 200 mg/day OR
   • 24 hour Urine Protein Excretion > 300 mg/day

6. Willing and able to sign informed consent

7. Willing to be approached about participation in interventional research studies

Exclusion criteria

1. Life-expectancy of less than 6 months
2. Currently receiving renal replacement therapy or planned to start in the next 6 months
3. Planned transplant in the next 6 months
4. Currently participating in a clinical trial involving investigational medicinal product (exception is participation in studies implemented through the GKPTN)

Trial design

5,999 participants in 1 patient group

Incident & Prevalent Patients

Description:

Incident and prevalent patients diagnosed with a kidney disease at participating centres