Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Condition: 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
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hypophosphatemia; Hyperparathyroidism
Intervention: Cinacalcet; Placebo
Intervention description: Possible sequential doses are 30, 60, 90, 120, and 180 mg.; Administered orally following the same dosing regimen as the experimental arm.
Intervention MeSH terms: Cinacalcet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intervention; Cinacalcet; Sensipar; Mimpara; hyperparathyroidism; calcium; osteodystrophy; hypercalcemia; renal; transplant; acute rejection; kidney transplant failure; hypophosphatemia

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.
    

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.