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Preservation of Kidney Function in Kidney Transplant Recipients by Alkali Therapy (Preserve-Transplant Study): a Multi-center Randomized Single-blind Placebo- Controlled Trial
The aim of this study is to test if alkali treatment will preserve kidney graft function and diminish the progression of chronic kidney disease in renal transplant patients. Additionally the underlying mechanisms of nephrotoxicity of metabolic acidosis will be investigated in this cohort. This study is a multi-center, prospective, randomized, single-blind (patient), placebo-controlled interventional trial to test the superiority of alkali treatment in comparison to placebo on preservation of kidney function in 300 kidney transplant recipients. The duration of the study will be 2 years for the individual participant. The patients will be randomized into 2 arms: intervention arm (sodium hydrogen carbonate, product: Nephrotrans®) and placebo arm (placebo comparator). Several studies in CKD (chronic kidney disease) patients have shown that alkali therapy slows progression of CKD.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Inselspital Bern, Department of Nephrology and Hypertension
Bern, Canton of Bern, Switzerland
HUG - Néphrologie
Geneva, Canton of Geneva, Switzerland
University Hospital Zurich, Division of Nephrology
Zurich, Canton of Zurich, Switzerland
Start Date
June 12, 2017
Primary Completion Date
June 29, 2021
Completion Date
July 26, 2021
Last Updated
April 22, 2022
240
ACTUAL participants
Nephrotrans
DRUG
Placebo
OTHER
Lead Sponsor
University of Zurich
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06366230