Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

NCT01011114 | Terminated FDA Drug

• 1 other identifier: 09-07-203
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypophosphatemia; Renal Transplant

Keywords

hypophosphatemia; hyperparathyroidism; renal transplant

Outcome Measures

Primary Outcomes (1)

• improvement in serum phosphorus

  3 months

Study Arms (2)

Cincalcet

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Interventions

Cinacalcet DRUG

cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.

Also known as: Sensipar

Cincalcet

Placebo DRUG

cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• renal transplant within last 3 months
• serum phosphorus less than 2.0 mg/dl
• serum creatinine less than 2.0 mg/dl

You may not qualify if:

• sensitivity to cinacalcet
• use of amitryptiline, desipramine, itraconazole, ketoconazole
• pregnancy

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Hypophosphatemia; Hyperparathyroidism

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Maria Coco, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: November 1, 2009
• Primary Completion: October 15, 2015
• Study Completion: October 15, 2015
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

US (1)