Global Kidney Patient Trials Network

NCT04389827 | Completed

• 1 other identifier: GKPTN2019
• Study Type: observational
• Target: 5,999
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Diseases

Keywords

Chronic Kidney Disease; Diabetic Nephropathy; Hypertensive Kidney Disease; Glomerulonephritis (GN); Focal Segmental Glomerulosclerosis (FSGS); Membranous Nephropathy; Minimal Change Disease; Immunoglobulin A Nephropathy (IgAN); Glomerulonephritis not otherwise specified; GN; FSGS

Outcome Measures

Primary Outcomes (2)

• estimated Glomerular Filtration Rate (eGFR)

  Routine results

  Collected Six-Monthly (minimum)

• Albuminuria

  Routine results

  Collected Six-Monthly (minimum)

Study Arms (1)

Incident & Prevalent Patients

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

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from units that provide a comprehensive nephrology service

You may qualify if:

• Documented diagnosis of primary kidney disease
• Regular visits (6-12 monthly) with a physician at a participating site that includes the monitoring of protein in urine and kidney function
• eGFR \> 25 ml/min/1.73m2
• ≥ 2 to ≥ 80 years of age
• 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
• hour Albumin Excretion \> 200 mg/day OR
• hour Urine Protein Excretion \> 300 mg/day
• Willing and able to sign informed consent
• Willing to be approached about participation in interventional research studies

You may not qualify if:

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

Sponsors & Collaborators

• The George Institute: lead
• Emerald Clinical Inc.: collaborator

Study Sites (1)

The George Institute

Sydney, New South Wales, 2031, Australia

Location

Related Publications (13)

• 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.

  PMID: 29904224 BACKGROUND

• 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.

  PMID: 22717317 BACKGROUND

• 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.

  PMID: 15385656 BACKGROUND

• 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.

  PMID: 21068142 BACKGROUND

• 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.

  PMID: 14747388 BACKGROUND

• 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.

  PMID: 30675428 BACKGROUND

• 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.

  PMID: 28797748 BACKGROUND

• 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.

  PMID: 28679092 BACKGROUND

• 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.

  PMID: 25799162 BACKGROUND

• 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.

  PMID: 30355464 BACKGROUND

• 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.

  PMID: 27406346 BACKGROUND

• 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.

  PMID: 22586319 BACKGROUND

• 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.

  PMID: 39661388 RESULT

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies; Hypertensive Nephropathy; Glomerulonephritis; Glomerulosclerosis, Focal Segmental; Glomerulonephritis, Membranous; Nephrosis, Lipoid; Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Nephritis; Autoimmune Diseases; Immune System Diseases; Nephrosis

Study Officials

• Hiddo Lambers Heerspink

  The George Institute

  PRINCIPAL INVESTIGATOR

• Sradha Kotwal

  The George Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 15, 2020
• Study Start: May 5, 2020
• Primary Completion: April 30, 2025
• Study Completion: October 31, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)