Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

Not Applicable

Terminated

• Conditions: Hypophosphatemia; Renal Transplant
• Interventions: Drug: Cinacalcet; Drug: Placebo

• Registration Number: NCT01011114
• Lead Sponsor: Montefiore Medical Center

Brief Summary

The purpose of the study is to determine whether cinacalcet, used in patients with secondary hyperparathyroidism to control excessive parathyroid hormone, can normalize low blood phosphorus that is commonly seen in patients who have had a kidney transplant.

Detailed Description

Secondary hyperparathyroidism (SHPT), common in ESRD, persists following renal transplantation resulting in profound hypophosphatemia. This can lead to hemolysis, congestive heart failure, rhabdomyolysis. Phosphate repletion is difficult in view of the persistent SHPT: oral phosphate supplementation can lead to hypocalcemia, reduced 1,25-OH Vitamin D production, hypercalcemia and further hyperparathyroidism. In addition, phospho-soda has been associated with phosphate nephropathy and renal failure.

Cinacalcet HCl is a calcimimetic agent that has recently become a standard therapy in the treatment of SHPT in ESRD. It suppresses PTH secretion by acting as a modulator of the Calcium-sensing receptor on the PTH cell, causing the PTH cell to decrease production of parathyroid hormone. It is a very effective agent, producing significant reduction of PTH as well as improvement in calcium and phosphate metabolism in the dialysis patient. The drug is well-tolerated with minimal adverse effects. Cinacalcet has also been used to control hypercalcemia in renal transplant patients with persistent hyperparathyroidism. Short-term cinacalcet given for 2 to 4 weeks has normalized serum phosphorus and decreased urinary phosphate wasting in renal transplant recipients with stable graft function.

We hypothesize that Cinacalcet HCl will normalize the hypophosphatemia of early renal transplant by reducing the effects of PTH on the proximal renal tubular transport of phosphorus, thereby allowing phosphate reabsorption and decreasing urinary phosphate wasting.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2015-10-15
• Study Completion: 2015-10-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• renal transplant within last 3 months
• serum phosphorus less than 2.0 mg/dl
• serum creatinine less than 2.0 mg/dl

Exclusion Criteria

• sensitivity to cinacalcet
• use of amitryptiline, desipramine, itraconazole, ketoconazole
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cincalcet	Cinacalcet	cinacalcet will be titrated as needed to achieve serum phosphorus of \> 2.5 mg/dl randomized, placebo-controlled trial comparing the effect of cinacalcet to placebo in controlling serum phosphorus. All subjects will receive oral phosphorus supplementation and Vitamin D as needed to maintain baseline Phosphorus at \~ 2.5 mg/l.
Control	Placebo	subjects will receive placebo pill titrated as needed to achieve phosphorus \> 2.5 mg/dl. randomized, placebo-controlled trial comparing the effect of cinacalcet to placebo in controlling serum phosphorus. All subjects will receive oral phosphorus supplementation and Vitamin D as needed to maintain baseline Phosphorus at \~ 2.5 mEq/l.

Primary Outcome Measures

Name	Time	Method
improvement in serum phosphorus	3 months

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States