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Preserve-Transplant Study

NCT03102996 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2022-04-22

No results posted yet for this study

Summary

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.

Conditions

  • Acidosis
  • Renal Insufficiency
  • Kidney Transplantation

Interventions

DRUG

Nephrotrans

Sodium hydrogen carbonate, ATC-Code: A02AH

OTHER

Placebo

Identical capsules without active substance.

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Nilufar Mohebbi, PD Dr. med. · University of Zurich

  • Rudolf P Wüthrich, Prof. Dr. med. · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2021-06-29
Completion
2021-07-26

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03102996 on ClinicalTrials.gov