UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003438 |
|---|---|
| Receipt number | R000004163 |
| Scientific Title | Cinacalcet and concurrent intravenous calcitriol for treatment of secondary hyperparathyroidism in dialysis patients compared with intravenous calcitriol alone |
| Date of disclosure of the study information | 2010/04/03 |
| Last modified on | 2013/02/24 23:39:27 |
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Basic information
Public title
Cinacalcet and concurrent intravenous calcitriol for treatment of secondary hyperparathyroidism in dialysis patients compared with intravenous calcitriol alone
Acronym
Comparison of cinacalcet and concurrent intravenous calcitriol with calcitriol alone
Scientific Title
Cinacalcet and concurrent intravenous calcitriol for treatment of secondary hyperparathyroidism in dialysis patients compared with intravenous calcitriol alone
Scientific Title:Acronym
Comparison of cinacalcet and concurrent intravenous calcitriol with calcitriol alone
Region
| Japan |
Condition
Condition
secondary hyperparathyroidism
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of cinacalcet and concurrent intravenous calcitriol with that of conventional intravenous calcitriol for treatment of secondary hyperparathyroidism in hemodialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.serum fibroblast growth factor 23 (FGF23)levels
2.bone metabolism markers.
Key secondary outcomes
1.bone mineral density.
2.serum biochemistry findings
3.the number and findings of enlarged parathyroid gland.
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
calcitriol i.v. for one year
Prolongation of the study period of another one year with maintaining the assignment of the patients
Interventions/Control_2
cinacalcet plus calcitriol i.v. for one year
Prolongation of the study period of another one year with maintaining the assignment of the patients
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The Hemodialysis duration is more than 12 weeks.
2. The score of intact PTH is between 60
pg/ml and 180pg/ml.
3. The score of albumin corrected serum
Ca is more than 8.5mg/dl.
4. Patients not changed in dialysate Ca
concentration within 2 weeks prior to the start of study treatment
5. Patients who given informed consent
Key exclusion criteria
1.severe liver dysfunction or cirrhosis
2.parathyroidectomy within the previous
24 weeks
3.patients receiving or likely to use
within 52 weeks of corticosteroid except for external use
4.use of bisphosphonate
5.pregnant or nursing
6.unsuitable patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | N Toshima-Minemura |
Organization
Seseragi Hospital
Division name
Internal medicine
Zip code
Address
1-1399 Ichiba-chou,
TEL
0270-63-6363
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | N Toshima-Minemura |
Organization
Seseragi Hospital
Division name
Internal medicine
Zip code
Address
1-1399 Ichiba-chou,
TEL
0270-63-6363
Homepage URL
toshima-n@seseragi-hosp.jp
Sponsor or person
Institute
1.Division of Internal medicine, Seseragi hospital
2.Department of Medicine & Biological Science Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
1.Department of Medicine & Biological Science Gunma University Graduate School of Medicine
2.Seseragi hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Department of Medicine & Biological Science Gunma University Graduate School of Medicine
Name of secondary funder(s)
1. a Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science
2.a grant from the Japan Cardiovascular Foundation
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
Seseragi Hospital(Gunma-ken)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 02 | Day |
Last modified on
| 2013 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004163
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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