UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004212 |
|---|---|
| Receipt number | R000005061 |
| Scientific Title | The effects of cinacalcet hydrochloride on the regression of the parathryoid gland hyperplasia |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2015/01/05 15:41:50 |
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Basic information
Public title
The effects of cinacalcet hydrochloride on the regression of the parathryoid gland hyperplasia
Acronym
REG study
Scientific Title
The effects of cinacalcet hydrochloride on the regression of the parathryoid gland hyperplasia
Scientific Title:Acronym
REG study
Region
| Japan |
Condition
Condition
Secondary hyperparathyroidism under hemodialysis therapy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical effects of cinacalcet on the parathyroid gland volume in patients with moderate to advanced secondary hyperparathyroidism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes in parathyroid gland volume after cinacalcet hydrochloride treatment
Key secondary outcomes
Serial changes in the serum levels of intact PTH, corrected calcium, phosphorus and alkaline phosphatase, and in the doses of drugs used for secondary hyperparathyroidism
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of cinacalcet hydrochloride to hemodialysis patients with moderate to advanced secondary hyperparathyroidism
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with a history of more than 6 months of hemodialysis therapy, 2) patients with secondary hyperparathyroidism refractory to conventional medical treatment, 3) patients with serum intact PTH of more than 180 pg/ml and serum corrected calcium of more than 9mg/dl, 4) patiens who newly start to recieve cinacalcet treatment
Key exclusion criteria
Patients who have a past history of surgical parathyroidectomy and percutaneous ethanol injection therapy are excluded. In addition, patients who have been suffered from lifethreatening medical conditios such as malignancy or severe infection.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Tsuruya |
Organization
Kyushu University
Division name
Department of Chronic Kidney Disease, Graduate School of Medical Science
Zip code
Address
3-1-1Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5843
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatomo Taniguchi |
Organization
Kyusuhu University
Division name
Department of Medicien and Clinical Science
Zip code
Address
3-1-1Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5843
Homepage URL
masatomo@kcu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Chronic Kidney Disease, Graduate School of Medical Science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Sicence, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukuoka Renal Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Two years of treatment with cinacalcet hydrochloride significantly decreased parathryoid gland volumes, independent of the baseline PTH values and parathyroid gland volumes in 60 hemodialysis patients with secondary hyperparathyroidism. During the treatment period, serum PTH valuse increased in some patients, indicating that some patients showed resistance to cinacalcet treatment.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 15 | Day |
Last modified on
| 2015 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005061
