Status:
WITHDRAWN
The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients
Lead Sponsor:
Prim. Priv. Doz. Dr. Daniel Cejka
Collaborating Sponsors:
Medice Arzneimittel Pütter GmbH & Co KG
Conditions:
Kidney Transplant; Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single-center, prospective, open-label, randomized, cross-over study.
Detailed 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 3...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years old
- Prevalent (≥ 6 months after kidney transplantation) kidney transplant recipients
- eGFR (CKD-EPI formula) between 10 and 50 ml/min/1.73 m²
- Patient has provided informed consent prior to initiation of any study related procedure
Exclusion
- Allergy to sodium bicarbonate or any component of Nephrotrans®, namely soy or peanuts (reported cross-reactivity to peanuts has been reported in patients with soy-allergy).
- Unstable clinical condition (e.g. uncontrolled heart failure, clinical uremia, uncontrolled hypertension, impending initiation of dialysis treatment…) as judged by the recruiting physician
- Pregnant and nursing (lactating) women
- Unwillingness to discontinue current medication with sodium bicarbonate
- Unwillingness to discontinue antacids containing aluminum, calcium carbonate, magnesium, lactate, citrate, bicarbonate or mixtures thereof
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03301558
Start Date
January 1 2026
End Date
December 31 2028
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria, 4020