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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
Sodium hydrogen carbonate, ATC-Code: A02AH
Identical capsules without active substance.
Inselspital Bern, Department of Nephrology and Hypertension
Bern, Canton of Bern, Switzerland
HUG - Néphrologie
Geneva, Canton of Geneva, Switzerland
University Hospital Zurich, Division of Nephrology
Zurich, Canton of Zurich, Switzerland
eGFR
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.
Time frame: 2 years
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