Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism
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Purpose
Active parathyroid glands among renal dialysis patients contribute to calcified and hardened blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. The investigators designed an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperparathyroidism Arterial Stiffness |
Drug: Cinacalcet |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Cincalcet Treatment on Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism |
- Aortic pulse wave velocity after the cinacalcet treatment [ Time Frame: change in aortic pulse wave velocity at 52 weeks from baseline ] [ Designated as safety issue: No ]as before
- Percent change in the values for parathyroid hormone levels [ Time Frame: within one year of treatment with cinacalcet ] [ Designated as safety issue: No ]Blood samples will be stored before and after treatment with cinacalcet for further analysis.
- Change in calcium levels [ Time Frame: within one year of treatment with cinacalcet ] [ Designated as safety issue: No ]as before
- Aortic pulse wave velocity after the cinacalcet treatment [ Time Frame: change in aortic pulse wave velocity at 26 weeks from baseline ] [ Designated as safety issue: No ]as stated in the description of Primary Outcome Measure
- Change in phosphorus levels [ Time Frame: within one year of cinacalcet treatment ] [ Designated as safety issue: No ]as before
- Change in calcium-phosphorus product [ Time Frame: within one year of cinacalcet treatment ] [ Designated as safety issue: No ]as before
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cinacalcet
Oral cinacalcet
|
Drug: Cinacalcet
starting with 25 mg daily dose with titration, maximum dose 100 mg daily
Other Name: Sensipar
|
Detailed Description:
Mineral metabolism disturbance and hyperparathyroidism contribute to arterial stiffness and vascular calcification. The vascular damage, in turn, contributes to significant cardiovascular morbidity and mortality of end-stage renal disease patients. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. We design an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- plasma parathyroid hormone level of at least 300 pg/ml (31.8 pmol/L)
- aged 18 or older on peritoneal dialysis for at least three months
- willingness to give written consent and comply with the study protocol
Exclusion Criteria:
- evidence of cancer, active infection or diseases with limited life expectancy
- diseases known to cause hypercalcaemia
- adjusted serum calcium level below 2.1 mmol/L (8.4 mg/dL) after correction for albumin
- participation in another interventional study within last 30 days of randomization
- history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
- patients receiving drugs with a narrow therapeutic index and metabolized by cytochrome P-450 2D6 (which is inhibited by cinacalcet): flecainide, thioridazine and most tricyclic antidepressants
Contacts and Locations| Hong Kong | |
| Prince of Wales Hospital, Chinese University of Hong Kong | Recruiting |
| Shatin, New Territories, Hong Kong, SAR | |
| Contact: Kai Ming Chow, MBChB 852-26323131 Chow_Kai_Ming@alumni.cuhk.net | |
| Principal Investigator: | Kai Ming Chow, MBChB | Chinese University of Hong Kong, Prince of Wales Hospital |
More Information
No publications provided
| Responsible Party: | Dr. Chow Kai Ming, Prince of Wales Hospital |
| ClinicalTrials.gov Identifier: | NCT01143987 History of Changes |
| Other Study ID Numbers: | CRE-2010.084-T |
| Study First Received: | June 10, 2010 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by Chinese University of Hong Kong:
|
hyperparathyroidism pulse wave velocity end-stage renal disease arterial stiffness |
Additional relevant MeSH terms:
|
Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013