Kidney Transplant; Complications
Conditions
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.
Interventions
DRUGLow dose sodium bicarbonate
1500 mg sodium bicarbonate
DRUGHigh dose sodium bicarbonate
3000 mg sodium bicarbonate
Sponsors
Prim. Priv. Doz. Dr. Daniel Cejka
Medice Arzneimittel Pütter GmbH & Co KG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serum bicarbonate levels | 12 weeks | The secondary outcome is change of serum bicarbonate levels between different study phases. |
Countries
Austria
Contacts
PRINCIPAL_INVESTIGATORDaniela Cejka, MD
Head of Nephrology
Outcome results
None listed