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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
Country [26] 0 0
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
Country [30] 0 0
Poland
State/province [30] 0 0
Gdansk
Country [31] 0 0
Poland
State/province [31] 0 0
Katowice
Country [32] 0 0
Poland
State/province [32] 0 0
Lodz
Country [33] 0 0
Poland
State/province [33] 0 0
Poznan
Country [34] 0 0
Poland
State/province [34] 0 0
Szczecin
Country [35] 0 0
Spain
State/province [35] 0 0
AndalucÃ-a
Country [36] 0 0
Spain
State/province [36] 0 0
Cataluña
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00975000