Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients
This study is currently recruiting participants.
Verified October 2011 by The University of Hong Kong
Sponsor:
The University of Hong Kong
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01447368
First received: October 4, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
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Purpose
We propose a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of SHPT, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification in endstage renal disease patients over 12 months. The change in arterial stiffening and bone mineral density as well as nutritional status will be evaluated as secondary objectives of this study.
| Condition | Intervention |
|---|---|
|
Kidney Failure Secondary Hyperparathyroidism Vascular Diseases |
Drug: Cinacalcet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Medical (Oral Cinacalcet) Therapy Versus Surgical Therapy (Total Parathyroidectomy) on Vascular/Valvular Calcification in Chronic Peritoneal Dialysis Patients With Secondary Hyperparathyroidism - A Pilot Study |
Resource links provided by NLM:
Further study details as provided by The University of Hong Kong:
Primary Outcome Measures:
- Change in coronary artery calcium score and heart valve calcium score [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in aortic pulse wave velocity [ Time Frame: week 24 and wk 52 ] [ Designated as safety issue: No ]
- change in parathyroid gland size (cinacalcet treatment arm only) [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
- change in left ventricular mass index [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
- change in left ventricular volume and function [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
- change in bone mineral density at forearm, spine and femur [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
- change in insulin resistance index [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
- Change in subjective global assessment [ Time Frame: wk 24 and 52 ] [ Designated as safety issue: No ]
- change in lean muscle mass [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
- change in resting energy expenditure [ Time Frame: wk 24 and wk 52 ] [ Designated as safety issue: No ]
- change in intact parathyroid hormone (iPTH) level [ Time Frame: Wk 12, 24, 36 and 52 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cinacalcet treatment |
Drug: Cinacalcet
oral cinacalcet 25mg once daily as a start and up titrated by 25mg daily according to response in lowering PTH and maximum oral dose allowed is 100mg daily
Other Name: Regpara
|
| Active Comparator: Surgical parathyroidectomy |
Drug: Cinacalcet
oral cinacalcet 25mg once daily as a start and up titrated by 25mg daily according to response in lowering PTH and maximum oral dose allowed is 100mg daily
Other Name: Regpara
|
Detailed Description:
Patients with severe secondary hyperparathyroidism (SHPT) are frequently complicated with vascular calcification. There is some suggestion that subtotal parathyroidectomy may reduce or stabilize vascular calcium scores in dialysis patients. Experimental data suggests that SHPT plays an important role in mediating uraemic arterial disease and that parathyroidectomy largely prevented the development of calcification. Cinacalcet has emerged as a novel therapy for the treatment of SHPT and has been shown to reduce the need for surgical parathyroidectomy. However, their effects on vascular and bone status have not been evaluatedand compared with parathyroidectomy.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ESRD patients on long-term peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 800pg/mL.
- Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
- Patients with age between 18 - 75 years.
Exclusion Criteria:
- Patients with background valvular heart disease
- Patients who are unfit for general anaesthesia
- Patients with acute myocardial infarction within recent two months
- Patients with poor general condition
- Patients with plans for living related kidney transplant within 1 year
- Patients with previous history of parathyroidectomy
- Patients with underlying malignancy
- Patients with hepatic dysfunction
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447368
Contacts
| Contact: Angela YM Wang, MD, PhD | 22554949 | aymwang@hku.hk |
Locations
| Hong Kong | |
| Queen Mary Hospital and Tung Wah Hospital | Recruiting |
| Hong Kong, Hong Kong, 0000 | |
| Contact: Angela YM Wang, MD, PhD 852-22554949 aymwang@hku.hk | |
| Principal Investigator: Angela YM Wang, MD, PhD | |
| Sub-Investigator: Wai-Kei Lo, FRCP | |
Sponsors and Collaborators
The University of Hong Kong
Investigators
| Principal Investigator: | Angela YM Wang, MD, PhD | University of Hong Kong, Queen Mary Hospital |
More Information
No publications provided
| Responsible Party: | The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01447368 History of Changes |
| Other Study ID Numbers: | CP-2015 |
| Study First Received: | October 4, 2011 |
| Last Updated: | October 4, 2011 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by The University of Hong Kong:
|
chronic kidney disease peritoneal dialysis secondary hyperparathyroidism |
parathyroidectomy vascular calcification cinacalcet |
Additional relevant MeSH terms:
|
Hyperparathyroidism Hyperparathyroidism, Secondary Renal Insufficiency Vascular Diseases Parathyroid Diseases |
Endocrine System Diseases Kidney Diseases Urologic Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013