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2018 ; 19
(1
): 177
Nephropedia Template TP
gab.com Text
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English Wikipedia
Preservation of kidney function in kidney transplant recipients by alkali therapy
(Preserve-Transplant Study): rationale and study protocol
#MMPMID30001705
Wiegand A
; Ritter A
; Graf N
; Arampatzis S
; Sidler D
; Hadaya K
; Müller TF
; Wagner CA
; Wüthrich RP
; Mohebbi N
BMC Nephrol
2018[Jul]; 19
(1
): 177
PMID30001705
show ga
BACKGROUND: Graft survival after kidney transplantation has significantly
improved within the last decades but there is a substantial number of patients
with declining transplant function and graft loss. Over the past years several
studies have shown that metabolic acidosis plays an important role in the
progression of Chronic Kidney Disease (CKD) and that alkalinizing therapies
significantly delayed progression of CKD. Importantly, metabolic acidosis is
highly prevalent in renal transplant patients and a recent retrospective study
has shown that metabolic acidosis is associated with increased risk of graft loss
and patient death in kidney transplant recipients. However, no prospective trial
has been initiated yet to test the role of alkali treatment on renal allograft
function. METHODS: The Preserve-Transplant Study is an investigator-initiated,
prospective, patient-blinded, multi-center, randomized, controlled phase-IV trial
with two parallel-groups comparing sodium bicarbonate to placebo. The primary
objective is to test if alkali treatment will preserve kidney graft function and
diminish the progression of CKD in renal transplant patients by assesing the
change in eGFR over 2 years from baseline. Additionally we want to investigate
the underlying pathomechanisms of nephrotoxicity of metabolic acidosis.
DISCUSSION: This study has the potential to provide evidence that alkali
treatment may slow or reduce the progression towards graft failure and
significantly decrease the rate of end stage renal disease (ESRD), thus
prolonging long-term graft survival. The implementation of alkali therapy into
the drug regimen of kidney transplant recipients would have a favorable
risk-benefit ratio since alkali supplements are routinely used in CKD patients
and represent a well-tolerated, safe and cost-effective treatment. TRIAL
REGISTRATION: ClinicalTrials.gov NCT03102996 . Trial registration was completed
on April 6, 2017.