Text Size

Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients

This study has been withdrawn prior to enrollment.
(low enrollment)
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00415584
First received: December 21, 2006
Last updated: November 3, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention
Secondary Hyperparathyroidism
Hypercalcemia
 Drug: Cinacalcet HCl

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • normalization of serum calcium

Secondary Outcome Measures:
  • changes in renal function
  • changes in bone mineral density
  • changes in bone turnover

Estimated Enrollment: 18
Study Start Date: January 2007
Estimated Study Completion Date: November 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415584

Locations
United States, New York
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
  More Information

No publications provided

Responsible Party: Maria Coco, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00415584     History of Changes
Other Study ID Numbers: 05-09-244
Study First Received: December 21, 2006
Last Updated: November 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
hypercalcemia
transplant

Additional relevant MeSH terms:
Hypercalcemia
Hyperparathyroidism
Hyperparathyroidism, Secondary
Calcium Metabolism Disorders
 Metabolic Diseases
Water-Electrolyte Imbalance
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013