Clinical trial NCT00975000: Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Keywords: Intervention
Cinacalcet
Sensipar
Mimpara
hyperparathyroidism
calcium
osteodystrophy
hypercalcemia
renal
transplant
acute rejection
kidney transplant failure
hypophosphatemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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)
timeFrame: Weeks 21 to 26 (EAP)
Secondary outcomes:
measure: Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck
timeFrame: Baseline and Week 52
measure: Change From Baseline to the EAP in Mean Serum Phosphorus
timeFrame: Baseline and the EAP (mean of Weeks 22, 24, and 26)
measure: Change From Baseline to Week 52 in eGFR
timeFrame: Baseline and Week 52
measure: Change From Baseline to the EAP in Corrected Total Calcium
timeFrame: Baseline and the EAP (mean of Weeks 22, 24, and 26)
measure: Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)
timeFrame: Baseline and the EAP (mean of Weeks 22, 24, and 26)
measure: Change From Baseline to the EAP in Urine Phosphorus
timeFrame: Baseline and the EAP (mean of Weeks 22, 24, and 26)
measure: Percentage of Participants With a Parathyroidectomy
timeFrame: 56 weeks
measure: Time to Parathyroidectomy
timeFrame: 56 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tempe
country: United States
facility: Research Site
state: Arizona
city: San Francisco
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: Springfield
country: United States
facility: Research Site
state: Massachusetts
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: New York
country: United States
facility: Research Site
state: New York
city: Bethlehem
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Camperdown
country: Australia
facility: Research Site
state: New South Wales
city: Westmead
country: Australia
facility: Research Site
state: New South Wales
city: Woodville South
country: Australia
facility: Research Site
state: South Australia
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Wien
country: Austria
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: London
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Bordeaux Cedex
country: France
facility: Research Site
city: Montpellier cedex 05
country: France
facility: Research Site
city: Nantes Cedex 1
country: France
facility: Research Site
city: Paris Cedex 15
country: France
facility: Research Site
city: Toulouse Cedex 09
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: MÃ¡laga
country: Spain
facility: Research Site
state: AndalucÃ-a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
state: CataluÃ±a
city: Madrid
country: Spain
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Geneva 14
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: