hyperkalemia transplantation immunosuppression
Conditions
Interventions
Trade Name: veltassa
Pharmaceutical Form: Powder and solvent for oral suspension
Sponsors
oslo university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Renal transplant recipients who receive Tacrolimus as part of their immunosuppressive therapy. 2. Recipients 18 years of age or older. 3. Hyperkalemia (K>5) 4. Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1.age < 18 years 2. Concomitant treatment with: diltiazem, verapamil, fenytoin, carbamazapin, fluconazole, ketoconazole, vorikonazole, erythromycin, clarithromycin. 3. Constipation 4. Hypomagnesemia less than 1,0 mg/dl after magnesium supplementation 5. Increased immunologic risk patient (DSA, ABO-incompatible transplant)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective to see if patiromer interacts with takrolimus;Secondary Objective: interaction with mycofenolate, effect on potassium level;Primary end point(s): AUC tac in the absence and presence of patiromer;Timepoint(s) of evaluation of this end point: after inclusion of all 13 patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): effect on mycophenolate genotyping effect on potassium level ;Timepoint(s) of evaluation of this end point: end of study | — |
Countries
Norway
Contacts
Public Contactgeir mjøen
Oslo University Hospital
Outcome results
None listed