Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients
Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients
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.
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.
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