Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00975000
First received: September 10, 2009
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant.


Condition Intervention Phase
Chronic Allograft Nephropathy
Chronic Kidney Disease
Chronic Renal Failure
Disordered Mineral Metabolism
End Stage Renal Disease
Hyperparathyroidism
Hypophosphatemia
Kidney Disease
Kidney Transplantation
Post Renal Transplantation
Drug: Cinacalcet
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Using Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Correction of hypercalcemia, defined as achievement of a mean corrected total serum calcium value < 10.2 mg/dL (2.55 mmol/L), during the Efficacy Assessment Phase (EAP) [ Time Frame: Weeks 21 to 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change in the bone mineral density at the femoral neck measured by dual X-ray absorptiometry (DXA) scan from baseline to Week 52 [ Time Frame: From baseline to Week 52 ] [ Designated as safety issue: No ]
  • Absolute change in mean serum phosphorus from baseline to the EAP [ Time Frame: From baseline to the EAP ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: September 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cinacalcet Drug: Cinacalcet

Possible sequential doses of the investigational product for titration are 30, 60, 90, 120, and 180 mg.

Subjects will be considered for dose adjustments of the investigational product and will be dispensed a new supply of investigational product at day 1, weeks 4, 8, 12, 16, 20, 22, 26, 34 and 42.

Subjects will be eligible for a dose increase once every 4 weeks during the dose-titration phase and at study visits during the maintenance phase. Dose escalation is permitted during the EAP. Dose escalation will be based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study.

Placebo Comparator: Placebo Drug: Placebo

Possible sequential doses of the investigational product for titration are 30, 60, 90, 120, and 180 mg.

Subjects will be considered for dose adjustments of the investigational product and will be dispensed a new supply of investigational product at day 1, weeks 4, 8, 12, 16, 20, 22, 26, 34 and 42.

Subjects will be eligible for a dose increase once every 4 weeks during the dose-titration phase and at study visits during the maintenance phase. Dose escalation is permitted during the EAP. Dose escalation will be based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study.


  Eligibility

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

Inclusion Criteria:

  • Received a kidney transplant ≥ 9 weeks at time of Screening and ≤ 24 months before first dose
  • May be the first kidney transplant or a repeat kidney transplant.
  • Subjects with a functional, stable kidney transplant, defined as MDRD estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 (CKD Stage 3 or better) at Screening.
  • Men or women ≥ 18 years at the start of Screening (ie, time of informed consent).
  • Corrected total serum calcium > 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2 values in Screening period.
  • iPTH > 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen 1 or Screen 2).

Exclusion Criteria:

  • Received cinacalcet therapy post-transplant for more than 14 days cumulatively post-transplant. If cinacalcet therapy was received for a total of 14 days or less post-transplant, there must be a 4-week washout before subject is eligible for screening (Note: This does not exclude pre-transplant use of cinacalcet).
  • Anticipated parathyroidectomy within 6 to12 months after Randomization.
  • Ongoing therapy with bisphosphonates or use within 6 months prior to Screening.
  • Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites or analogues) or use within 30 days prior to Screening.
  • Ongoing use of calcium supplements or use within 30 days prior to Screening.
  • Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30 days prior to Screening.
  • Ongoing use of a thiazide diuretic.
  • Subjects with a history of seizures who had a seizure within the 3 months prior to Randomization, which required adjustments to the seizure medication.
  • Acute Kidney Injury (AKI) or renal biopsy within 6 weeks prior to Screening, unless it is an institutional protocol-driven biopsy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975000

  Show 51 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00975000     History of Changes
Other Study ID Numbers: 20062007
Study First Received: September 10, 2009
Last Updated: January 9, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
United States: Western Institutional Review Board

Keywords provided by Amgen:
Intervention
Cinacalcet
Sensipar
Mimpara
hyperparathyroidism
calcium
osteodystrophy
hypercalcemia
renal
transplant
acute rejection
kidney transplant failure
hypophosphatemia

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism
Hypophosphatemia
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014