secondary hyperparathyroidism
Conditions
Interventions
calcitriol i.v. for one year Prolongation of the study period of another one year with maintaining the assignment of the patients
cinacalcet plus calcitriol i.v. for one year Prolongation of the
Sponsors
1.Division of Internal medicine, Seseragi hospital 2.Department of Medicine & Biological Science Gunma University Graduate School of Medicine
Department of Medicine &
Biological Science Gunma University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The Hemodialysis duration is more than 12 weeks. 2. The score of intact PTH is between 60 pg/ml and 180pg/ml. 3. The score of albumin corrected serum Ca is more than 8.5mg/dl. 4. Patients not changed in dialysate Ca concentration within 2 weeks prior to the start of study treatment 5. Patients who given informed consent
Exclusion criteria
Exclusion criteria: 1.severe liver dysfunction or cirrhosis 2.parathyroidectomy within the previous 24 weeks 3.patients receiving or likely to use within 52 weeks of corticosteroid except for external use 4.use of bisphosphonate 5.pregnant or nursing 6.unsuitable patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.serum fibroblast growth factor 23 (FGF23)levels 2.bone metabolism markers. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.bone mineral density. 2.serum biochemistry findings 3.the number and findings of enlarged parathyroid gland. | — |
Countries
Japan
Contacts
Public ContactN Toshima-Minemura
Seseragi Hospital Internal medicine
Outcome results
None listed