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The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients

Kidney Transplant; Complications Clinical Trial

Official title:
The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients

Clinical Trial Summary

This is a single-center, prospective, open-label, randomized, cross-over study.

Clinical Trial Description

The primary hypothesis (H1) is that the T50 value will change between wash-out and high-dose (3000mg/d) sodium bicarbonate (Nephrotrans®) substitution. The 0-hypothesis (H0) is that substitution of 3000 mg/d sodium bicarbonate (Nephrotrans®) has no effect on T50-values as compared to wash-out-phase. Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between. Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between. The study will start with an initial run-in wash-out phase, where all sodium bicarbonate or other alkalizing treatment taken by the patient as standard of care will be discontinued. Consequently, there will be a sodium bicarbonate treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another sodium bicarbonate treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 ±3 days of duration. Patients will be followed up to 12weeks after randomization until the last study visit of the final wash-out phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03301558
Study type Interventional
Source Elisabethinen Hospital
Contact
Status Withdrawn
Phase Phase 2
Start date January 1, 2024
Completion date December 31, 2025
View Details
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