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Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00975000
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : January 29, 2016
Last Update Posted : October 17, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : December 3, 2009
Actual Primary Completion Date : September 13, 2012
Actual Study Completion Date : April 16, 2013

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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).

  2. Change From Baseline to the EAP in Mean Serum Phosphorus [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
  3. 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.

  4. Change From Baseline to the EAP in Corrected Total Calcium [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
  5. Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH) [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
  6. Change From Baseline to the EAP in Urine Phosphorus [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
  7. Percentage of Participants With a Parathyroidectomy [ Time Frame: 56 weeks ]
  8. Time to Parathyroidectomy [ Time Frame: 56 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00975000

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Sponsors and Collaborators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen Identifier: NCT00975000    
Other Study ID Numbers: 20062007
First Posted: September 11, 2009    Key Record Dates
Results First Posted: January 29, 2016
Last Update Posted: October 17, 2018
Last Verified: September 2018
Keywords provided by Amgen:
acute rejection
kidney transplant failure
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists