Patients with uncontrolled secondary hyperparathyroidism and who are on haemodialysis Nutritional, Metabolic, Endocrine Hyperparathyroidism and other disorders of parathyroid gland
Conditions
Interventions
Intervention arm: Cinacalcet (oral) alongside standard therapy. Dose of cinacalcet will be adjusted according to PTH and calcium, within the range of 30-180 mg daily.
Control arm: Standard therapy al
Sponsors
Salford Royal NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-75 at recruitment, both male and female 2. On haemodialysis for >90 days 3. Parathyroid hormone (PTH) >=300 pg/ml 4. Corrected calcium >=2.1 mmol/l
Exclusion criteria
Exclusion criteria: 1. Atrial fibrillation 2. Any contra-indications to magnetic resonance (MR) scan or ability to cooperate with scan 3. Any factors which will influence computed tomography (CT) scan e.g. artificial heart valves, previous sternotomy wires, stents 4. Contra-indication to cinacalcet e.g., pregnant, breast feeding, known reaction 5. Moderate to severe liver disease (alanine transaminase [ALT] >3x normal) 6. Have a poor record of compliance with medication 7. Have participated in a study involving an investigational drug during the 30 days prior to the first visit 8. Be involved in any other research study which exposes the patient to radiation above that of normal clinical practice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of calcification score between the 2 cohorts at baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the following will be compared between the 2 arms at baseline and 12 months: 1. Vascular stiffness 2. Cardiac morphology 3. Cardiac function 4. Bone mineral density 5. Carotid Intima Media Thickness (CIMT) 6. Serum markers | — |
Countries
United Kingdom
Outcome results
None listed