Preserve-Transplant Study

Summary

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.

Timeline

Start

2017-06-12

Primary completion

2021-06-29

Completion

2021-07-26

Publications

• Staub PS, Kronthaler D, Wiegand A, Dahdal S, Sidler D, Arampatzis S, Hadaya K, Seeger H, Wuthrich RP, Held U, Wagner CA, Mohebbi N, Ritter A. Effect of Sodium Bicarbonate on Indicators of Volume Retention in Metabolic Acidosis After Kidney Transplantation: A Post-Hoc Analysis. Kidney Med. 2026 Feb 11;8(4):101290. doi: 10.1016/j.xkme.2026.101290. eCollection 2026 Apr.
• Mohebbi N, Ritter A, Wiegand A, Graf N, Dahdal S, Sidler D, Arampatzis S, Hadaya K, Mueller TF, Wagner CA, Wuthrich RP. Sodium bicarbonate for kidney transplant recipients with metabolic acidosis in Switzerland: a multicentre, randomised, single-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Feb 18;401(10376):557-567. doi: 10.1016/S0140-6736(22)02606-X. Epub 2023 Jan 25.
• Wiegand A, Ritter A, Graf N, Arampatzis S, Sidler D, Hadaya K, Muller TF, Wagner CA, Wuthrich RP, Mohebbi N. Preservation of kidney function in kidney transplant recipients by alkali therapy (Preserve-Transplant Study): rationale and study protocol. BMC Nephrol. 2018 Jul 13;19(1):177. doi: 10.1186/s12882-018-0956-8.

Drugs

Indications