Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

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.

Study Overview

• Status: Terminated
• Conditions: Renal Transplant; Hypophosphatemia
• Intervention / Treatment: Drug: Cinacalcet; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cincalcet; 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.	Drug: Cinacalcet; cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.; Other Names: Sensipar
Placebo Comparator: Control; 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.	Drug: Placebo; cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
improvement in serum phosphorus	3 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Maria Coco, MD, MS, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 15, 2015
• Study Completion (Actual): October 15, 2015

Study Registration Dates

• First Submitted: November 9, 2009
• First Submitted That Met QC Criteria: November 10, 2009
• First Posted (Estimate): November 11, 2009

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: renal transplant; hyperparathyroidism; hypophosphatemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hypophosphatemia; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Calcium-Regulating Hormones and Agents; Calcimimetic Agents; Cinacalcet
• Other Study ID Numbers: 09-07-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No