The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients
Study Details
Study Description
Brief Summary
This is a single-center, prospective, open-label, randomized, cross-over study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Low dose sodium bicarbonate Low dose 1500 mg sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take one capsule with breakfast, one with lunch and one with dinner (schedule 1-1-1). |
Drug: Low dose sodium bicarbonate
1500 mg sodium bicarbonate
Other Names:
|
| Active Comparator: High Dose sodium bicarbonate High dose 3000 mg of sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take two capsules with breakfast, two with lunch and two with dinner (schedule 2-2-2). |
Drug: High dose sodium bicarbonate
3000 mg sodium bicarbonate
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Propensity of serum for calcification [12 weeks]
The primary outcome is change in the mean T50 values between different study phases (treatment vs. control).
Secondary Outcome Measures
- Serum bicarbonate levels [12 weeks]
The secondary outcome is change of serum bicarbonate levels between different study phases.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ordensklinikum Linz GmbH Elisabethinen | Linz | Upper Austria | Austria | 4020 |
Sponsors and Collaborators
- Prim. Priv. Doz. Dr. Daniel Cejka
- Medice Arzneimittel Pütter GmbH & Co KG
Investigators
- Principal Investigator: Daniela Cejka, MD, Head of Nephrology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KTR-Bic-T50