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Kidney DiseasesGKPTNNCT04389827

Global Kidney Patient Trials Network

An observational study of Kidney Diseases, run by The George Institute at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 2 to 80 years
Conditions the study is for
Kidney Diseases
How many people
5,999 participants
Where
1 siteAustralia
Study dates
5 May 2020to 31 Oct 2025
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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
Show all 12Show fewer
  • 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
  • Willing and able to sign informed consent
  • Willing to be approached about participation in interventional research studies

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The George Institute

    Sydney, New South Wales, 2031

Other trials in Australia

About this study

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
Medical subject headings
Kidney Diseases, Renal Insufficiency, Chronic, Diabetic Nephropathies, Hypertensive Nephropathy, Glomerulonephritis, Glomerulosclerosis, Focal Segmental, Glomerulonephritis, Membranous, Nephrosis, Lipoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04389827
Study groupRoleWhat they receive
Incident & Prevalent PatientsIncident and prevalent patients diagnosed with a kidney disease at participating centres

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. estimated Glomerular Filtration Rate (eGFR)

    Routine results

    Measured: Collected Six-Monthly (minimum)

  2. Albuminuria

    Routine results

    Measured: Collected Six-Monthly (minimum)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2020
  2. Study start5 May 2020
  3. Primary completion30 Apr 2025
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,999 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04389827
Sponsor's protocol ID
GKPTN2019
Acronym
GKPTN
Status last verified
Dec 2025
First submitted
4 May 2020
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The current plan is that only aggregate data will be shared for research purposes. Individual participant data would only be reviewed in incidental findings and only be discussed with the participant in question.

Publications

  • 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.

    PubMed 29904224

  • 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.

    PubMed 22717317

  • 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.

    PubMed 15385656

  • 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.

    PubMed 21068142

  • 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.

    PubMed 14747388

  • 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.

    PubMed 30675428

  • 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.

    PubMed 28797748

  • 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.

    PubMed 28679092

  • 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.

    PubMed 25799162

  • 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.

    PubMed 30355464

  • 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.

    PubMed 27406346

  • 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.

    PubMed 22586319

  • 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.

    PubMed 39661388

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Diseases, run by The George Institute at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

estimated Glomerular Filtration Rate (eGFR) (time frame: Collected Six-Monthly (minimum)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04389827, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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