Nephrotrans
DrugSodium hydrogen carbonate, ATC-Code: A02AH
NCT Number: NCT03102996
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Inselspital Bern, Department of Nephrology and Hypertension, Bern, Canton of Bern, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sodium hydrogen carbonate, ATC-Code: A02AH
Identical capsules without active substance.
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.
University of Zurich
Other
Preservation of Kidney Function in Kidney Transplant Recipients by Alkali Therapy (Preserve-Transplant Study): a Multi-center Randomized Single-blind Placebo- Controlled Trial
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