Cinacalcet, effects on cardiovascular and bone health in chronic kidney disease (CKD)
| ISRCTN | ISRCTN81718275 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81718275 |
| Protocol serial number | 2006VAS23 |
| Sponsor | Salford Royal NHS Foundation Trust (UK) |
| Funders | Amgen, educational grant (USA), University of Manchester, Translational Imaging Unit grant (UK) |
- Submission date
- 24/04/2008
- Registration date
- 31/07/2008
- Last edited
- 06/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philip Kalra
Scientific
Scientific
H4 Renal Department
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom
| Phone | +44 (0)161 206 5998 |
|---|---|
| philip.kalra@srft.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre randomised open-label interventional study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial to examine the effects of calcimimetic therapy on bone and cardiovascular health in end-stage renal disease |
| Study objectives | Null hypothesis: Cinacalcet will have no effect on the change of bone and cardiovascular parameters, compared to standard therapy, in haemodialysis patients over a 12 month period. |
| Ethics approval(s) | Salford and Trafford Local Research Ethics Committee, approved in November 2005 (ref: 05/Q1404/216) |
| Health condition(s) or problem(s) studied | Patients with uncontrolled secondary hyperparathyroidism and who are on haemodialysis |
| Intervention | 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 alone. Standard therapy includes vitamin D analogues and all available phosphate binders. Duration of interventions: 12 months |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cinacalcet |
| Primary outcome measure(s) |
The change of calcification score between the 2 cohorts at baseline and 12 months |
| Key secondary outcome measure(s) |
The change in the following will be compared between the 2 arms at baseline and 12 months: |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
H4 Renal Department
Salford
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/05/2016: No publications found, verifying study status with principal investigator.
