TerminatedPhase 1/2

Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients

Stopped: Based on information in IRB archives the study was terminated in 2009 due to low enrollment

United States4 participantsStarted 2007-02-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * Allergic to Cinacalcet HCl, tetracycline * Pregnant * On medication that utilizes same liver system as Cinacalcet HCl

What they're measuring

Normalization of Serum Calcium Levels

Timeframe: Baseline to 6 Months

Trial details

NCT IDNCT00415584

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2024-09-19

View on ClinicalTrials.gov More Secondary Hyperparathyroidism trials