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NCT02973607: CRIB-DONOR II

Effects of a Reduction in Renal Function on Cardiovascular Structure and Function

Completed Last updated 5 October 2020
What this trial tests

trial testing Nephrectomy in Chronic Kidney Disease in 95 participants. Completed in 31 July 2020.

Timeline
23 May 2017
Primary endpoint
20 March 2020
31 July 2020

Quick facts

Lead sponsorUniversity Hospital Birmingham NHS Foundation Trust
StatusCompleted
Study typeOBSERVATIONAL
Enrollment95
Start date23 May 2017
Primary completion20 March 2020
Estimated completion31 July 2020
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital Birmingham NHS Foundation Trust

Who can join

Adults 18 to 80, any sex, with Chronic Kidney Disease or Hypertrophy, Left Ventricular. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic kidney disease (CKD) is present in 1 in 7 of the population and confers a high risk of cardiovascular disease. The pathophysiology of cardiovascular disease in CKD is poorly understood because CKD is always accompanied by confounding factors including the underlying disease process (e.g. diabetes mellitus, systemic vasculitis) and the consequences of CKD including hypertension, anaemia and inflammation. Nephrectomy in kidney donors causes a 30% reduction in renal function providing an ideal study population to measure prospectively the effects of reduced kidney function on the cardiovascular system. The CRIB-Donor study (ClinicalTrials.gov Identifier:NCT01028703) demonstrated adverse effects on cardiovascular structure and function at 12 months compared to controls including an increase in left ventricular mass. This proposal will measure the changes in cardiovascular structure and function, cardiovascular age and biochemical changes at 5 years providing information on the long term effects of reduced renal function.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cardiovascular Effects of Unilateral Nephrectomy in Living Kidney Donors at 5 Years.
    Price AM, Moody WE, Stoll VM, Vijapurapu R, et al · · 2021 · cited 14× · PMID 33550822 · DOI 10.1161/hypertensionaha.120.15398

Verify or expand the search:

Other trials of Nephrectomy

Trials testing the same drug.

Other recruiting trials for Chronic Kidney Disease

Currently open trials in the same condition.

Other University Hospital Birmingham NHS Foundation Trust trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing