Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Montefiore Medical Center.
Recruitment status was  Recruiting
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

November 9, 2009
October 22, 2012
November 2009
November 2013   (final data collection date for primary outcome measure)
improvement in serum phosphorus [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01011114 on ClinicalTrials.gov Archive Site
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Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Hypophosphatemia
  • Renal Transplant
  • Drug: Cinacalcet
    cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.
    Other Names:
    • cinacalcet
    • Sensipar
  • Drug: Placebo
    cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.
  • 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.
    Intervention: Drug: Cinacalcet
  • 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.

    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Maria Coco, MD,MS 718-920-4136 mcoco@montefiore.org
United States
 
NCT01011114
09-07-203
No
Maria Coco, Montefiore Medical Center
Montefiore Medical Center
Not Provided
Principal Investigator: Maria Coco, MD, MS Montefiore Medical Center
Montefiore Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP