Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

Renal Transplant Clinical Trial

Official title:

Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01011114
• Other study ID #: 09-07-203
• Status: Terminated
• Phase: N/A
• Start date: November 2009
• Est. completion date: October 15, 2015

Study information

• Verified date: April 2021
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: October 15, 2015
• Est. primary completion date: October 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypophosphatemia
• Renal Transplant

Intervention

Drug:
• Cinacalcet
cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.
• Placebo
cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in serum phosphorus		3 months