Text Size

Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

This study is currently recruiting participants.
Verified October 2012 by Montefiore Medical Center
Sponsor:
Information provided by (Responsible Party):
Maria Coco, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01011114
First received: November 9, 2009
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Hypophosphatemia
Renal Transplant
 Drug: Cinacalcet
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • improvement in serum phosphorus [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • cinacalcet
  • 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011114

Contacts
Contact: Maria Coco, MD,MS 718-920-4136 mcoco@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Principal Investigator: Maria Coco, MD,MS            
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Maria Coco, MD, MS Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Maria Coco, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01011114     History of Changes
Other Study ID Numbers: 09-07-203
Study First Received: November 9, 2009
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
hypophosphatemia
hyperparathyroidism
renal transplant

Additional relevant MeSH terms:
Hypophosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013