Hypercalcemia with persistent hyperparathyroidism in renal transplant recipients.
Conditions
Interventions
Sponsors
St Marianna University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.kidney transplant recipient(living or cadaver) at least 6 months after transplantation. 2.Persistent hyperparathyroidism with hypercalcemia [serum intact-PTH greater than 65 pg/ml and corrected serum calcium concentration greater than 10.3 mg/dl by Payne equation cCa = (4- measured albumin)+measured calcium]. 3.Stable kidney function with eGFR greater than 30 ml/min/1.73m2 over the last 3 months. 4.No need for change in doses of maintenance immunosuppressive therapy over the last 3 months within target trough levels. (Cyclosporine:trough 50-150 ng/ml, Tacrolimus:trough 5-10 ng/ml) 5.Agreed to verbal and written informed concent.
Exclusion criteria
Exclusion criteria: 1.age below 20 years old or pregnant 2.those who cannot agree to the study 3.inappropriate patients judged by primary or study physicians. 4.history of allergy or severe side effects by cinacalcet 5.those with severe liver dysfunction 6.concomitant use of vitamin D sterols, phosphate binder, calcium supplementation, bisphosphonates within 2 weeks before start of the study 7.history of parathyroidectomy or percutaneous ethanol injection therapy to parathyroid glands.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute or relative changes in serum calcium, phosphate and intact-PTH levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute or relative changes of parathyroid grands size, bone density, vascular stiffness and bone metabolism markers (vitamin D, FGF23) and safety evaluations (by kidney function, interaction with immunosuppressives) | — |
Countries
Japan
Contacts
Public ContactMasahiko Yazawa
St Marianna University Nephrology and Hypertension
Outcome results
None listed