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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00975000




Registration number
NCT00975000
Ethics application status
Date submitted
10/09/2009
Date registered
11/09/2009
Date last updated
17/10/2018

Titles & IDs
Public title
Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Scientific 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
Secondary ID [1] 0 0
20062007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Allograft Nephropathy 0 0
Chronic Kidney Disease 0 0
Chronic Renal Failure 0 0
Disordered Mineral Metabolism 0 0
End Stage Renal Disease 0 0
Hyperparathyroidism 0 0
Hypophosphatemia 0 0
Kidney Disease 0 0
Kidney Transplantation 0 0
Post Renal Transplantation 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cinacalcet
Treatment: Drugs - Placebo

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.

Placebo comparator: Placebo - Participants received placebo orally once daily for 52 weeks.


Treatment: Drugs: Cinacalcet
Possible sequential doses are 30, 60, 90, 120, and 180 mg.

Treatment: Drugs: Placebo
Administered orally following the same dosing regimen as the experimental arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Weeks 21 to 26 (EAP)
Secondary outcome [1] 0 0
Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [2] 0 0
Change From Baseline to the EAP in Mean Serum Phosphorus
Timepoint [2] 0 0
Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary outcome [3] 0 0
Change From Baseline to Week 52 in eGFR
Timepoint [3] 0 0
Baseline and Week 52
Secondary outcome [4] 0 0
Change From Baseline to the EAP in Corrected Total Calcium
Timepoint [4] 0 0
Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary outcome [5] 0 0
Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)
Timepoint [5] 0 0
Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary outcome [6] 0 0
Change From Baseline to the EAP in Urine Phosphorus
Timepoint [6] 0 0
Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary outcome [7] 0 0
Percentage of Participants With a Parathyroidectomy
Timepoint [7] 0 0
56 weeks
Secondary outcome [8] 0 0
Time to Parathyroidectomy
Timepoint [8] 0 0
56 weeks

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/04/2013
Sample size
Target
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Westmead
Recruitment hospital [3] 0 0
Research Site - Woodville South
Recruitment hospital [4] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Austria
State/province [13] 0 0
Wien
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
France
State/province [20] 0 0
Bordeaux Cedex
Country [21] 0 0
France
State/province [21] 0 0
Montpellier cedex 05
Country [22] 0 0
France
State/province [22] 0 0
Nantes Cedex 1
Country [23] 0 0
France
State/province [23] 0 0
Paris Cedex 15
Country [24] 0 0
France
State/province [24] 0 0
Toulouse Cedex 09
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
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Germany
State/province [26] 0 0
Kiel
Country [27] 0 0
Italy
State/province [27] 0 0
Genova
Country [28] 0 0
Italy
State/province [28] 0 0
Milano
Country [29] 0 0
Italy
State/province [29] 0 0
Padova
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Poland
State/province [30] 0 0
Gdansk
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Poland
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Katowice
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Poland
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Lodz
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Poland
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Poznan
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Poland
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Szczecin
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Spain
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AndalucÃ-a
Country [36] 0 0
Spain
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Cataluña
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Spain
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Madrid
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Switzerland
State/province [38] 0 0
Bern
Country [39] 0 0
Switzerland
State/province [39] 0 0
Geneva 14
Country [40] 0 0
Switzerland
State/province [40] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00975000
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00975000