Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000695000
Ethics application status
Approved
Date submitted
13/08/2010
Date registered
23/08/2010
Date last updated
23/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Parathyroid gland size and responsiveness to cinacalcet therapy in hemodialysis patients with secondary hyperparathyroidism
Scientific title
Parathyroid gland size and responsiveness to cinacalcet therapy in hemodialysis patients with secondary hyperparathyroidism
Secondary ID [1] 1089 0
CRG020800134 (Cochrane Renal Group)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemodialysis patients with secondary hyperparathyroidism 243804 0
Condition category
Condition code
Renal and Urogenital 258124 258124 0 0
Kidney disease
Metabolic and Endocrine 258192 258192 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cinacalcet hydrochloride, 25 mg once daily, given orally, for 52 weeks. The doses were increased to the next sequential daily dose in the series 25, 50, 75, and 100 mg after at least a 3-week interval if their intact parathyroid hormone was >180 pg/ml at the previous study visit, unless serum calcium was <8.4 mg/dl.
Intervention code [1] 257012 0
Treatment: Drugs
Comparator / control treatment
Results were compared with historical controls who had been treated with traditional therapy alone, including phosphate binders and vitamin D sterols. Historical data were derived from patients who met the same eligibility criteria as trial participants and had undergone ultrasonography twice at an interval of 1 year between 2000 and 2008.
Control group
Historical

Outcomes
Primary outcome [1] 240873 0
Proportion of patients with a mean intact parathyroid hormone <180 pg/ml, as evaluated by the Elecsys assay, during the efficacy-assessment phase.
Timepoint [1] 240873 0
After 52-weeks of treatment
Secondary outcome [1] 257543 0
Proportion of patients with a <30% reduction from baseline in intact parathyroid hormone, as evaluated by the Elecsys assay.
Timepoint [1] 257543 0
After 52-weeks of treatment
Secondary outcome [2] 265243 0
Percent change from baseline in calcium, phosphorus, and intact parathyroid hormone, as evaluated by the Elecsys assay.
Timepoint [2] 265243 0
After 52-weeks of treatment
Secondary outcome [3] 265244 0
Change from baseline in parathyroid gland volume, as evaluated by ultrasonography.
Timepoint [3] 265244 0
After 52-weeks of treatment

Eligibility
Key inclusion criteria
1. Receiving maintenance dialysis for at least 16 weeks
2. Serum intact parathyroid hormone >300 pg/mL
3. Corrected serum calcium >9.0 mg/dL
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of parathyroidectomy or an unstable medical condition during the previous 30 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 2126 0
Japan
State/province [1] 2126 0

Funding & Sponsors
Funding source category [1] 257466 0
Charities/Societies/Foundations
Name [1] 257466 0
The Kidney Foundation
Country [1] 257466 0
Japan
Primary sponsor type
University
Name
Kobe University School of Medicine
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017
Country
Japan
Secondary sponsor category [1] 256692 0
Hospital
Name [1] 256692 0
Konan Hospital
Address [1] 256692 0
1-5-16 Kamokogahara, Higashinada-ku, Kobe, 658-0064
Country [1] 256692 0
Japan
Secondary sponsor category [2] 256715 0
Hospital
Name [2] 256715 0
Sumiyoshigawa Hospital
Address [2] 256715 0
5-6-7 Konan-cho, Higashinada-ku, Kobe, 658-0084
Country [2] 256715 0
Japan
Secondary sponsor category [3] 256716 0
Hospital
Name [3] 256716 0
Chibune Kidney and Dialysis Clinic
Address [3] 256716 0
3-1-11 Tsukuda, Nishiyodogawa-ku, Osaka, 555-0001
Country [3] 256716 0
Japan
Secondary sponsor category [4] 256717 0
Hospital
Name [4] 256717 0
Akebono Clinic
Address [4] 256717 0
5-1-1 Shirafuji, Kumamoto, 861-4112
Country [4] 256717 0
Japan
Secondary sponsor category [5] 256718 0
Hospital
Name [5] 256718 0
Sumiyoshi Clinic Hospital
Address [5] 256718 0
193-97 Sumiyoshicho, Mito, 310-0844
Country [5] 256718 0
Japan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259491 0
Kobe University School of Medicine
Ethics committee address [1] 259491 0
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017
Ethics committee country [1] 259491 0
Japan
Date submitted for ethics approval [1] 259491 0
01/10/2007
Approval date [1] 259491 0
01/01/2008
Ethics approval number [1] 259491 0
643

Summary
Brief summary
The purpose of this study was twofold: (1) to elucidate whether parathyroid gland size could be used as an indicator of response to cinacalcet therapy and (2) to examine whether cinacalcet reduces parathyroid gland volume in patients with secondary hyperparathyroidism.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30258 0
Address 30258 0
Country 30258 0
Phone 30258 0
Fax 30258 0
Email 30258 0
Contact person for public queries
Name 13505 0
Masafumi Fukagawa
Address 13505 0
Division of Nephrology and Kidney Center, Kobe University School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
Country 13505 0
Japan
Phone 13505 0
+81 78 382 6500
Fax 13505 0
+81 78 382 6509
Email 13505 0
fukagawa@med.kobe-u.ac.jp
Contact person for scientific queries
Name 4433 0
Masafumi Fukagawa
Address 4433 0
Division of Nephrology and Kidney Center, Kobe University School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
Country 4433 0
Japan
Phone 4433 0
+81 78 382 6500
Fax 4433 0
+81 78 382 6509
Email 4433 0
fukagawa@med.kobe-u.ac.jp

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.