Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5999 participants
OBSERVATIONAL
2020-05-05
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Incident & Prevalent Patients
Incident and prevalent patients diagnosed with a kidney disease at participating centres
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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)
2 Years
80 Years
ALL
No
Sponsors
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Emerald Clinical Inc.
INDUSTRY
The George Institute
OTHER
Responsible Party
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Principal Investigators
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Hiddo Lambers Heerspink
Role: PRINCIPAL_INVESTIGATOR
The George Institute
Sradha Kotwal
Role: PRINCIPAL_INVESTIGATOR
The George Institute
Locations
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The George Institute
Sydney, New South Wales, Australia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Kotwal SS, Perkovic V, Jardine MJ, Kim D, Shah NA, Lin E, Coggan S, Billot L, Vart P, Wheeler DC, de Boer IH, Zhang H, Hou FF, Sugawara Y, Marion J, Lewis RJ, Berry LR, McGlothlin A, Jha V, De Nicola L, Gorriz JL, Heerspink HJL; GKPTN and CAPTIVATE Investigators. The Global Kidney Patient Trials Network and the CAPTIVATE Platform Clinical Trial Design: A Trial Protocol. JAMA Netw Open. 2024 Dec 2;7(12):e2449998. doi: 10.1001/jamanetworkopen.2024.49998.
Related Links
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International Diabetes Federation (IDF). IDF Diabetes Atlas 8th edn. Brussels, Belgium:: International Diabetes Federation; 2017
Other Identifiers
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GKPTN2019
Identifier Type: -
Identifier Source: org_study_id
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