UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000391 |
|---|---|
| Receipt number | R000000482 |
| Scientific Title | An open label randomized controlled trial on the preemptive risedronate intervention for renal transplant patients receiving glucocorticoid |
| Date of disclosure of the study information | 2006/04/01 |
| Last modified on | 2006/10/18 14:24:27 |
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Basic information
Public title
An open label randomized controlled trial on the preemptive risedronate intervention for renal transplant patients receiving glucocorticoid
Acronym
The Preemptive Risedronate Intervention for those Undergoing Steroid therapy after Renal Transplantation (PRIUS-RTx Study)
Scientific Title
An open label randomized controlled trial on the preemptive risedronate intervention for renal transplant patients receiving glucocorticoid
Scientific Title:Acronym
The Preemptive Risedronate Intervention for those Undergoing Steroid therapy after Renal Transplantation (PRIUS-RTx Study)
Region
| Japan |
Condition
Condition
Bone disease in renal transplant patients receiving glucocorticoid
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of risedronate on bone disease in renal transplant patients receiving glucocorticoid
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in bone mineral density and bone turnover markers at two-year interval
Key secondary outcomes
Ca, iP, PTH, and indices of renal function. Safety.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Active vitamin D alone (2 year)
Interventions/Control_2
Active vitamin D + risedronate (2 year)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Renal transplant patients receiving glucocorticoid treatment (2.5 mg/day of prednisolone equivalent or greater) with low bone mineral density (T-score at the lumbar spine <= -1.0) and stable renal function (serum creatinine <= 2.0 mg/dL).
Key exclusion criteria
1. Previous history of bisphosphonate treatment and/or hormone replacement therapy within one year before entry
2. Contraindication for risedronate or active vitamin D
3. Not suitable to the clinical trial as judged by a physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Takahara |
Organization
Osaka University School of Medicine
Division name
Department of Advanced Technology for Transplantation
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University School of Medicine
Division name
Department of Advanced Technology for Transplantation,
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-5111
Homepage URL
Sponsor or person
Institute
Department of Advanced Technology for Transplantation, Osaka University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
CRG040600075
Org. issuing International ID_1
Cochrane Renal Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 04 | Month | 01 | 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
Date of protocol fixation
| 2003 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 10 | 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
| 2006 | Year | 04 | Month | 01 | Day |
Last modified on
| 2006 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000482
