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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20062007

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