Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00415584
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 34
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Secondary hyperparathyroidism can persist following successful renal transplantation and can cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other problems. If the condition does not resolve, surgery is frequently required to remove the parathyroid glands, with all the inherent risks of surgery. Cinacalcet, a medicine used to treat secondary hyperparathyroidism in patients with kidney disease, may be effective in treating this condition in the renal transplant recipient. We will study the effect of cinacalcet on calcium, bone and renal function in a 6 month treatment protocol.

Condition or Disease	Intervention/Treatment	Phase
Secondary Hyperparathyroidism; Hypercalcemia	Drug: Cinacalcet HCl	Phase 1/Phase 2

Detailed Description

Secondary Hyperparathyroidism in the renal transplant recipient can cause abnormal bone and mineral metabolism, resulting in hypercalcemia that is detrimental to renal function, causing renal dysfunction and calcinosis. These patients often require parathyroidectomy to correct the hypercalcemia. Surgery is not without significant risk to the patient. Risks include vocal cord paralysis, protracted hypocalcemia, cardiac arrhythmias, muscle cramps. In addition, parathyroidectomy has been associated with subsequent renal impairment.

Cinacalcet is a calcimimetic agent that is very effective in the treatment of secondary hyperparathyroidism in patients with renal failure as well as in hypercalcemia of parathyroid cancer. There have been reports of short term Cinacalcet use in renal transplant recipients. Serum calcium was improved in these patients.

However, little is known about the effect of cinacalcet on bone activity and turnover. It is not known whether Cinacalcet causes low turnover bone activity with adynamic bone disease. It is known that low turnover bone disease in renal patients can by itself cause hypercalcemia as the bone becomes static and unable to respond to everyday calcium loads.

We have shown that adynamic bone can develop in renal transplant recipients under a variety of conditions. It is not known what effect, if any, cinacalcet has on the bone activity of renal transplant recipients with persistent secondary hyperparathyroidism.

The purpose of the study is to determine the effect of Cinacalcet on serum calcium, renal function and bone histology in renal transplant recipients.

This is a prospective, open-label study. Stable adult renal transplant recipients who are at least 3 months post renal transplant, are hypercalcemic and have persistent hyperparathyroidism with inappropriately elevated Parathyroid hormone will be eligible.

Protocol procedures will include baseline and 6 month measurements of bone mineral density, bone biochemical parameters, glomerular filtration rate, anterior iliac crest bone biopsy. Subjects will start cinacalcet after the first biopsy. The medication will be titrated to normalize serum calcium. Medication will be supplied by the study. Serum electrolytes will be monitored as indicated.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cinacalcet for Treatment of Persistent Secondary Hyperparathyroidism in Renal Transplant Recipients: Effect on Renal Function, Serum Calcium and Bone Histomorphometry
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cinacalcet HCl	Drug: Cinacalcet HCl

Outcome Measures

Primary Outcome Measures

1. normalization of serum calcium []

Secondary Outcome Measures

1. changes in renal function []

2. changes in bone mineral density []

3. changes in bone turnover []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• renal transplant recipient at least 3 months post transplant

• hypercalcemia

• hyperparathyroidism

Exclusion Criteria:

• allergic to cinacalcet, tetracycline.

• pregnancy

• on medication that utilize same liver system as cinacalcet Hcl

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

• Principal Investigator: Maria Coco, MD, MS, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT00415584
• Other Study ID Numbers: 05-09-244
• First Posted: Dec 25, 2006
• Last Update Posted: Apr 23, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Keywords provided by Montefiore Medical Center: hypercalcemia; transplant
• Additional relevant MeSH terms: Neoplasm Metastasis; Hypercalcemia; Hyperparathyroidism; Hyperparathyroidism, Secondary; Cinacalcet

Study Results

No Results Posted as of Apr 23, 2021