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Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Maria Coco, Montefiore Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01011114
First Posted: November 11, 2009
Last Update Posted: October 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maria Coco, Montefiore Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

Resource links provided by NLM:


Further study details as provided by Maria Coco, Montefiore Medical Center:

Primary Outcome Measures:
  • improvement in serum phosphorus [ Time Frame: 3 months ]

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 Name: 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Maria Coco, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01011114     History of Changes
Other Study ID Numbers: 09-07-203
First Submitted: November 9, 2009
First Posted: November 11, 2009
Last Update Posted: October 23, 2012
Last Verified: October 2012

Keywords provided by Maria Coco, Montefiore Medical Center:
hypophosphatemia
hyperparathyroidism
renal transplant

Additional relevant MeSH terms:
Hypophosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs