Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415584
Status:
TERMINATED
Last Update Posted:
2021-04-23
First Post:
2006-12-21
Brief Title:
Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Cinacalcet for Treatment of Persistent Secondary Hyperparathyroidism in Renal Transplant Recipients Effect on Renal Function Serum Calcium and Bone Histomorphometry
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None