Global Kidney Patient Trials Network

Kidney Diseases Clinical Trial

Official title:

Global Kidney Patient Trials Network

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04389827
• Other study ID #: GKPTN2019
• Status: Recruiting
• Start date: May 5, 2020
• Est. completion date: April 1, 2030

Study information

• Verified date: January 2023
• Source: The George Institute
• Contact: FanHan Hsu
• Phone: +61 2 8052 4511
• Email: gkptn[@]georgeinstitute.org.au
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: April 1, 2030
• Est. primary completion date: April 1, 2025
• 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/1.73m2

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

2. Currently receiving renal replacement therapy or planned to start in the next 6 months

3. Currently participating in a clinical trial involving investigational medicinal product (exception is participation in studies implemented through the GKPTN)

Related Conditions & MeSH terms

• Kidney Diseases

Locations

Country	Name	City	State
Australia	The George Institute	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute	George Clinical Pty Ltd

Country where clinical trial is conducted

Australia, 

References & Publications (12)

Berry SM, Connor JT, Lewis RJ. The platform trial: an efficient strategy for evaluating multiple treatments. JAMA. 2015 Apr 28;313(16):1619-20. doi: 10.1001/jama.2015.2316. No abstract available. — View 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. — 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

Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR Jr, Tsao A, Stewart DJ, Hicks ME, Erasmus J Jr, Gupta S, Alden CM, Liu S, Tang X, Khuri FR, Tran HT, Johnson BE, Heymach JV, Mao L, Fossella F, Kies MS, Papadimitrakopoulou V, Davis SE, Lippman SM, Hong WK. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov. 2011 Jun;1(1):44-53. doi: 10.1158/2159-8274.CD-10-0010. Epub 2011 Jun 1. — 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

Park JW, Liu MC, Yee D, Yau C, van 't Veer LJ, Symmans WF, Paoloni M, Perlmutter J, Hylton NM, Hogarth M, DeMichele A, Buxton MB, Chien AJ, Wallace AM, Boughey JC, Haddad TC, Chui SY, Kemmer KA, Kaplan HG, Isaacs C, Nanda R, Tripathy D, Albain KS, Edmiston KK, Elias AD, Northfelt DW, Pusztai L, Moulder SL, Lang JE, Viscusi RK, Euhus DM, Haley BB, Khan QJ, Wood WC, Melisko M, Schwab R, Helsten T, Lyandres J, Davis SE, Hirst GL, Sanil A, Esserman LJ, Berry DA; I-SPY 2 Investigators. Adaptive Randomization of Neratinib in Early Breast Cancer. N Engl J Med. 2016 Jul 7;375(1):11-22. doi: 10.1056/NEJMoa1513750. — View Citation

Parker CC, James ND, Brawley CD, Clarke NW, Hoyle AP, Ali A, Ritchie AWS, Attard G, Chowdhury S, Cross W, Dearnaley DP, Gillessen S, Gilson C, Jones RJ, Langley RE, Malik ZI, Mason MD, Matheson D, Millman R, Russell JM, Thalmann GN, Amos CL, Alonzi R, Bahl A, Birtle A, Din O, Douis H, Eswar C, Gale J, Gannon MR, Jonnada S, Khaksar S, Lester JF, O'Sullivan JM, Parikh OA, Pedley ID, Pudney DM, Sheehan DJ, Srihari NN, Tran ATH, Parmar MKB, Sydes MR; Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial. Lancet. 2018 Dec 1;392(10162):2353-2366. doi: 10.1016/S0140-6736(18)32486-3. Epub 2018 Oct 21. — 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

Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70. doi: 10.1056/NEJMra1510062. No abstract available. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimated Glomerular Filtration Rate (eGFR)	Routine results	Collected Six-Monthly (minimum)
Primary	Albuminuria	Routine results	Collected Six-Monthly (minimum)

External Links

•   International Diabetes Federation (IDF). IDF Diabetes Atlas 8th edn. Brussels, Belgium:: International Diabetes Federation; 2017