Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients

NCT00415584 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 05-09-244
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 renal transplant recipients. The investigator team will study the effect of cinacalcet on calcium, bone and renal function in a 6 month treatment protocol.

Conditions

Secondary Hyperparathyroidism; Hypercalcemia

Keywords

hypercalcemia; transplant

Outcome Measures

Primary Outcomes (1)

• Normalization of Serum Calcium Levels

  Serum calcium was to have been assessed by drawing venous blood samples for serum analysis. Normal blood calcium levels for adults range from approximately 8.5 to 10.4 mg/dL, but vary depending on laboratory reference ranges. Changes in serum calcium levels from baseline following treatment with Cinacalcet HCl were to have been summarized and evaluated using paired t-tests.

  Baseline to 6 Months

Secondary Outcomes (2)

• Changes in Renal Function

  Baseline to 6 Months

• Changes in Bone Mineral Density

  Baseline to 6 Months

Other Outcomes (1)

• Changes in Bone Turnover Rate

  Baseline to 6 Months

Study Arms (1)

Cinacalcet Hydrochloride (HCl)

EXPERIMENTAL

Drug: Cinacalcet HCl

Interventions

Cinacalcet HCl DRUG

Cinacalcet Hydrochloride (HCl)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Renal transplant recipient at least 3 months post transplant
• Hypercalcemic, with serum calcium \> 10.5 milliequivalents per liter (mEq/L)
• Persistent hyperparathyroidism, with inappropriately elevated parathyroid hormone (PTH)

You may not qualify if:

• Allergic to Cinacalcet HCl, tetracycline
• Pregnant
• On medication that utilizes same liver system as Cinacalcet HCl

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Hypercalcemia

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

Limitations attributable to the collection of DXA bone mineral density scans along with incomplete collections attributable to study design and logistics issues led to incomplete/unreliable results which were unable to be generalized. As indicated in the Change within Bone Mineral Density Outcome Measure, results data for this assessment were limited to basic summaries.

Results Point of Contact

• Title: Dr. Maria Coco
• Organization: Montefiore Medical Center

mcoco@montefiore.org

718-920-4136

Study Officials

• Maria Coco, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dept of Medicine (Nephrology)

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 25, 2006
• Study Start: February 9, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Locations

US (1)