Alkali Treatment for Kidney Graft Function Preservation in Renal Transplant Patients
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.
Nephrotrans
+ Placebo
Urogenital Diseases+13
+ Acid-Base Imbalance
+ Acidosis
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.240 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy 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
Inselspital Bern, Department of Nephrology and Hypertension
Bern, SwitzerlandOpen Inselspital Bern, Department of Nephrology and Hypertension in Google MapsHUG - Néphrologie
Geneva, SwitzerlandUniversity Hospital Zurich, Division of Nephrology
Zurich, Switzerland