NCT03102996

Preserve-Transplant Study

Preservation of Kidney Function in Kidney Transplant Recipients by Alkali Therapy (Preserve-Transplant Study): a Multi-center Randomized Single-blind Placebo- Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acidosis
• Renal Insufficiency
• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Nephrotrans	Sodium hydrogen carbonate, ATC-Code: A02AH
OTHER	Placebo	Identical capsules without active substance.

Timeline

• Start date: 2017-06-12
• Primary completion: 2021-06-29
• Completion: 2021-07-26
• First posted: 2017-04-06
• Last updated: 2022-04-22

Locations

3 sites across 1 country: Switzerland