Clinical trial NCT03301558: The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients
Official title: The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Kidney Transplant; Complications
Lead sponsor: Elisabethinen Hospital
Sponsor class: OTHER
Collaborators: name: Medice Arzneimittel Pütter GmbH & Co KG
First posted: 2017-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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 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.

Eligibility 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

Primary outcomes:
measure: Propensity of serum for calcification
timeFrame: 12 weeks
Secondary outcomes:
measure: Serum bicarbonate levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
state: Upper Austria
Study officials:
affiliation: Head of Nephrology
name: Daniela Cejka, MD
role: PRINCIPAL_INVESTIGATOR
References: