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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05036850
Other study ID # CKPTN2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 27, 2021
Est. completion date February 28, 2031

Study information

Verified date March 2023
Source George Clinical Pty Ltd
Contact FanHan Hsu
Phone +61 2 8052 4300
Email CKPTN@georgeclinical.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date February 28, 2031
Est. primary completion date September 15, 2026
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China George Clinical (Beijing) Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
George (Beijing) Clinical Research Co. Ltd.

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. Erratum In: N Engl J Med. 2008;18(4):4. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary eGFR (estimated Glomerular Filtration Rate) Routine results Collected six monthly, up to 5 years
Primary Albuminuria Routine results Collected six monthly, up to 5 years
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