NCT05036850

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
58mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Sep 2021Feb 2031

First Submitted

Initial submission to the registry

August 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2031

Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

5 years

First QC Date

August 27, 2021

Last Update Submit

March 3, 2023

Conditions

Keywords

Chronic Kidney DiseaseDiabetic NephropathyHypertensive Kidney DiseaseGlomerulonephritisGNFocal Segmental GlomerulosclerosisFSGSMembranous NephropathyMinimal Change DiseaseIgA NephropathyGlomerulonephritis not otherwise specified

Outcome Measures

Primary Outcomes (2)

  • eGFR (estimated Glomerular Filtration Rate)

    Routine results

    Collected six monthly, up to 5 years

  • Albuminuria

    Routine results

    Collected six monthly, up to 5 years

Study Arms (1)

Incident and Prevalent Patients

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

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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 (at least 6 monthly) with a physician at a participating site
  • eGFR \> 15 ml/min/1.73 m2
  • ≥ 2 years of age
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Clinical (Beijing)

Beijing, Beijing Municipality, 100125, China

RECRUITING

Related Publications (7)

  • 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: 29904224BACKGROUND
  • 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: 22717317BACKGROUND
  • 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: 15385656BACKGROUND
  • 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: 21068142BACKGROUND
  • 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: 14747388BACKGROUND
  • 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: 30675428BACKGROUND
  • 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: 28797748BACKGROUND

MeSH Terms

Conditions

Kidney DiseasesRenal Insufficiency, ChronicDiabetic NephropathiesHypertensive NephropathyGlomerulonephritisGlomerulosclerosis, Focal SegmentalGlomerulonephritis, MembranousNephrosis, LipoidGlomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesNephritisAutoimmune DiseasesImmune System DiseasesNephrosis

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 8, 2021

Study Start

September 27, 2021

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

February 28, 2031

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

The current plan is that only aggregate data will be shared for research purposes. IPD would only be reviewed in incidental findings and only be discussed with the participant in question.

Locations