Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

September 20, 2018 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Research Site
      • Westmead, New South Wales, Australia, 2145
        • Research Site
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Research Site
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Research Site
  • Austria
      • Wien, Austria, 1090
        • Research Site
  • Belgium
      • Brussels, Belgium, 1200
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Research Site
      • Ottawa, Ontario, Canada, K1H 7W9
        • Research Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Research Site
  • France
      • Bordeaux Cedex, France, 33076
        • Research Site
      • Montpellier cedex 05, France, 34295
        • Research Site
      • Nantes Cedex 1, France, 44093
        • Research Site
      • Paris Cedex 15, France, 75743
        • Research Site
      • Toulouse Cedex 09, France, 31403
        • Research Site
  • Germany
      • Berlin, Germany, 13353
        • Research Site
      • Kiel, Germany, 24105
        • Research Site
  • Italy
      • Genova, Italy, 16132
        • Research Site
      • Milano, Italy, 20122
        • Research Site
      • Padova, Italy, 35128
        • Research Site
  • Poland
      • Gdansk, Poland, 80-952
        • Research Site
      • Katowice, Poland, 40-027
        • Research Site
      • Lodz, Poland, 90-153
        • Research Site
      • Poznan, Poland, 60-539
        • Research Site
      • Szczecin, Poland, 70-111
        • Research Site
  • Spain
      • Madrid, Spain, 28041
        • Research Site
    • AndalucÃ-a
      • Málaga, AndalucÃ-a, Spain, 29010
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08036
        • Research Site
      • Barcelona, Cataluña, Spain, 08025
        • Research Site
      • L'Hospitalet de Llobregat, Cataluña, Spain, 08907
        • Research Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Research Site
      • Geneva 14, Switzerland, 1211
        • Research Site
      • Zurich, Switzerland, 8091
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Research Site
      • Tempe, Arizona, United States, 85284
        • Research Site
    • California
      • San Francisco, California, United States, 94143
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
      • Evanston, Illinois, United States, 60201
        • Research Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
    • New York
      • New York, New York, United States, 10032
        • Research Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 (chromic kidney disease 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cinacalcet
Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parthyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.
Drug: Cinacalcet
Possible sequential doses are 30, 60, 90, 120, and 180 mg.
Other Names:
  • Mimpara
  • Sensipar
Placebo Comparator: Placebo
Participants received placebo orally once daily for 52 weeks.
Drug: Placebo
Administered orally following the same dosing regimen as the experimental arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With 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 (EAP)
Weeks 21 to 26 (EAP)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck
Time Frame: Baseline and Week 52
Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).
Baseline and Week 52
Change From Baseline to the EAP in Mean Serum Phosphorus
Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26)
Baseline and the EAP (mean of Weeks 22, 24, and 26)
Change From Baseline to Week 52 in eGFR
Time Frame: Baseline and Week 52
eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Baseline and Week 52
Change From Baseline to the EAP in Corrected Total Calcium
Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26)
Baseline and the EAP (mean of Weeks 22, 24, and 26)
Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)
Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26)
Baseline and the EAP (mean of Weeks 22, 24, and 26)
Change From Baseline to the EAP in Urine Phosphorus
Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26)
Baseline and the EAP (mean of Weeks 22, 24, and 26)
Percentage of Participants With a Parathyroidectomy
Time Frame: 56 weeks
56 weeks
Time to Parathyroidectomy
Time Frame: 56 weeks
56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2009

Primary Completion (Actual)

September 13, 2012

Study Completion (Actual)

April 16, 2013

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20062007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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