Clinical trial NCT05036850: China Kidney Patient Trials Network
Official title: China Kidney Patient Trials Network
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Diseases
Keywords: Chronic Kidney Disease
Diabetic Nephropathy
Hypertensive Kidney Disease
Glomerulonephritis
GN
Focal Segmental Glomerulosclerosis
FSGS
Membranous Nephropathy
Minimal Change Disease
IgA Nephropathy
Glomerulonephritis not otherwise specified
Lead sponsor: George Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 1200
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from units that provide a comprehensive nephrology service

Brief summary: This is a prospective multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease in China.


Eligibility criteria: Inclusion Criteria:

1. Documented diagnosis of primary kidney disease
2. Regular visits (at least 6 monthly) with a physician at a participating site
3. eGFR \> 15 ml/min/1.73 m2
4. ≥ 2 years of age
5. Willing and able to sign informed consent
6. Willing to be approached about participation in interventional research studies

Exclusion Criteria:

* 1. Life-expectancy of less than 6 months

Primary outcomes:
measure: eGFR (estimated Glomerular Filtration Rate)
timeFrame: Collected six monthly, up to 5 years
measure: Albuminuria
timeFrame: Collected six monthly, up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: George Clinical (Beijing)
state: Beijing
Study officials:
References:
citation: Luyckx VA, Tonelli M, Stanifer JW. The global burden of kidney disease and the sustainable development goals. Bull World Health Organ. 2018 Jun 1;96(6):414-422D. doi: 10.2471/BLT.17.206441. Epub 2018 Apr 20.
citation: Tonelli M, Muntner P, Lloyd A, Manns BJ, Klarenbach S, Pannu N, James MT, Hemmelgarn BR; Alberta Kidney Disease Network. Risk of coronary events in people with chronic kidney disease compared with those with diabetes: a population-level cohort study. Lancet. 2012 Sep 1;380(9844):807-14. doi: 10.1016/S0140-6736(12)60572-8. Epub 2012 Jun 19.
citation: Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
citation: McGrogan A, Franssen CF, de Vries CS. The incidence of primary glomerulonephritis worldwide: a systematic review of the literature. Nephrol Dial Transplant. 2011 Feb;26(2):414-30. doi: 10.1093/ndt/gfq665. Epub 2010 Nov 10.
citation: Strippoli GF, Craig JC, Schena FP. The number, quality, and coverage of randomized controlled trials in nephrology. J Am Soc Nephrol. 2004 Feb;15(2):411-9. doi: 10.1097/01.asn.0000100125.21491.46.
citation: Perkovic V, Craig JC, Chailimpamontree W, Fox CS, Garcia-Garcia G, Benghanem Gharbi M, Jardine MJ, Okpechi IG, Pannu N, Stengel B, Tuttle KR, Uhlig K, Levey AS. Action plan for optimizing the design of clinical trials in chronic kidney disease. Kidney Int Suppl (2011). 2017 Oct;7(2):138-144. doi: 10.1016/j.kisu.2017.07.009. Epub 2017 Sep 20.
citation: de Zeeuw D, Heerspink HJL, Jardine M, Perkovic V. Renal trials in diabetes need a platform: time for a global approach? Lancet Diabetes Endocrinol. 2018 May;6(5):356-358. doi: 10.1016/S2213-8587(17)30263-2. Epub 2017 Aug 7. No abstract available.