Completed

Alkali Treatment for Kidney Graft Function Preservation in Renal Transplant Patients

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Study Aim

This study aims to evaluate the effectiveness of alkali treatment in preserving kidney graft function in renal transplant patients, by observing changes in renal function through the eGFR measure over a period of 2 years.

What is being tested

Nephrotrans

+ Placebo

DrugOther
Who is being recruted

Urogenital Diseases+13

+ Acid-Base Imbalance

+ Acidosis

Over 18 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: June 2017
See protocol details

Summary

Principal SponsorUniversity of Zurich
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 12, 2017

Actual date on which the first participant was enrolled.

This study focuses on kidney transplant recipients, aiming to find out if a treatment called alkali therapy can help preserve kidney function and slow down the progression of chronic kidney disease. The study is particularly important as it could potentially improve the care and quality of life for individuals who have undergone a kidney transplant. Previous research has suggested that alkali therapy might slow down the worsening of chronic kidney disease. In this study, 300 kidney transplant recipients will participate for a duration of 2 years. They will be randomly assigned to two groups: one group will receive the alkali treatment in the form of a product called Nephrotrans®, while the other group will receive a placebo. The study is designed in such a way that only the researchers, not the participants, will know who is receiving the actual treatment. The main outcome of interest is the change in kidney function, which will be measured using a standard method called the CKD-EPI creatinine equation.

Official TitlePreservation of Kidney Function in Kidney Transplant Recipients by Alkali Therapy (Preserve-Transplant Study): a Multi-center Randomized Single-blind Placebo- Controlled Trial
NCT03102996
Principal SponsorUniversity of Zurich
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAcid-Base ImbalanceAcidosisChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

7 inclusion criteria required to participate
Informed consent as documented by signature

age ≥ 18 years and able to give informed consent

≥ 12 months after renal transplantation

stable clinical condition

Show More Criteria

16 exclusion criteria prevent from participating
uncontrolled hypertension or use of > 4 antihypertensive agents

uncontrolled heart failure

serum potassium < 3.0 mmol/l

serum sodium > 150 mmol/l

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patients will receive Nephrotrans.

Group II

Placebo
Patients will receive Placebo.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Inselspital Bern, Department of Nephrology and Hypertension

Bern, SwitzerlandOpen Inselspital Bern, Department of Nephrology and Hypertension in Google Maps
Suspended

HUG - Néphrologie

Geneva, Switzerland
Suspended

University Hospital Zurich, Division of Nephrology

Zurich, Switzerland
Completed3 Study Centers