Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00415584 |
| Other study ID # |
05-09-244 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 2007 |
| Est. completion date |
November 2009 |
Study information
| Verified date |
April 2021 |
| Source |
Montefiore Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
