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|ClinicalTrials.gov Identifier: NCT03102996|
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : August 6, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Acidosis Renal Insufficiency Kidney Transplantation||Drug: Nephrotrans Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Preservation of Kidney Function in Kidney Transplant Recipients by Alkali Therapy (Preserve-Transplant Study): a Multi-center Randomized Single-blind Placebo- Controlled Trial|
|Actual Study Start Date :||June 12, 2017|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||July 2021|
Patients will receive Nephrotrans.
Sodium hydrogen carbonate, ATC-Code: A02AH
Placebo Comparator: Placebo
Patients will receive Placebo.
Identical capsules without active substance.
- eGFR [ Time Frame: 2 years ]Change in renal function by assessing the change in eGFR over 2 years from baseline. eGFR will be determined based on the CKD-EPI creatinine equation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102996
|Inselspital Bern, Department of Nephrology and Hypertension|
|Bern, BE, Switzerland|
|HUG - Néphrologie|
|Geneva, GE, Switzerland|
|University Hospital Zurich, Division of Nephrology|
|Zurich, ZH, Switzerland|
|Principal Investigator:||Nilufar Mohebbi, PD Dr. med.||University of Zurich|
|Study Director:||Rudolf P Wüthrich, Prof. Dr. med.||University of Zurich|