Project

Metabolic acidosis: changes in bone mineral metabolism after bicarbonate treatment in kidney transplantation

Ongoing - recruitment closed ยท 2024 until 2025

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Ongoing - recruitment closed
Start Date
2024
End Date
2025
Financing
KSSG, SNF
Phase
IV
Study Design
RCT, post hoc analysis
Partner
Prof. Dr. Carsten A. Wagner, Prof. Dr. Nilufar Mohebbi, Dr. Suzan Dahdal, PD Dr. Karine Hadaya
Brief description/objective

Metabolic acidosis (MA) is a frequent complication in kidney transplantation (KTx). Chronic MA after KTx is associated with impaired mineral metabolism and growth retardation in children. After transplantation, skeletal health may be particularly susceptible to MA as kidney transplant recipients (KTRs) often not only suffer from CKD-mineral and bone disorders (MBD) but also receive glucocorticoids. In contrast to non-transplant CKD, no guidelines exist yet for MA treatment after KTx. In a post hoc analysis of prospectively collected data and samples of the Preserve-Transplant Study (PTS), a multicentric randomized, placebo-controlled, single-blind trial, we aim to test the effect of bicarbonate loading compared to placebo on bone density, a predefined outcome of interest, mineral metabolism and on circulating markers of bone metabolism with the use of biobank samples. The PTS is the only large randomized-controlled alkali trial in KTRs with MA. It comprised 240 study subjects and was primarily designed to assess the impact of sodium bicarbonate on allograft function. Further analysis of this randomized controlled population of KTRs is a unique opportunity with high clinical relevance to study the effect of bicarbonate treatment on bone metabolism in MA.