Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

NCT ID: NCT00975000

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-03
• Study Completion Date: 2013-04-16

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cinacalcet

Intervention Type: DRUG

Possible sequential doses are 30, 60, 90, 120, and 180 mg.

Placebo

Participants received placebo orally once daily for 52 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally following the same dosing regimen as the experimental arm.

Interventions

Cinacalcet

Possible sequential doses are 30, 60, 90, 120, and 180 mg.

Intervention Type: DRUG

Placebo

Administered orally following the same dosing regimen as the experimental arm.

Intervention Type: DRUG

Other Intervention Names

Mimpara; Sensipar

Eligibility 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 (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Research Site

Phoenix, Arizona, United States

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Tempe, Arizona, United States

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San Francisco, California, United States

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Aurora, Colorado, United States

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Gainesville, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Evanston, Illinois, United States

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Springfield, Massachusetts, United States

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Detroit, Michigan, United States

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New York, New York, United States

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Bethlehem, Pennsylvania, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Camperdown, New South Wales, Australia

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Westmead, New South Wales, Australia

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Woodville South, South Australia, Australia

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Parkville, Victoria, Australia

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Vienna, , Austria

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Bordeaux, , France

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Montpellier, , France

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Nantes, , France

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Paris, , France

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Toulouse, , France

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Berlin, , Germany

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Kiel, , Germany

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Genova, , Italy

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Milan, , Italy

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Padua, , Italy

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Gdansk, , Poland

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Katowice, , Poland

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Lodz, , Poland

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Poznan, , Poland

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Szczecin, , Poland

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Málaga, AndalucÃ-a, Spain

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Barcelona, Cataluña, Spain

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Barcelona, Cataluña, Spain

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L'Hospitalet de Llobregat, Cataluña, Spain

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Madrid, , Spain

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Bern, , Switzerland

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Geneva, , Switzerland

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Zurich, , Switzerland

Countries

United States; Australia; Austria; Belgium; Canada; France; Germany; Italy; Poland; Spain; Switzerland

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20062007

Identifier Type: -

Identifier Source: org_study_id