UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000475 |
|---|---|
| Receipt number | R000000495 |
| Scientific Title | Therapeutic strategy of relative hypoparathyroidism in hemodialysis patients using sevelamer hydrochloride, with special reference to vitamin D administration |
| Date of disclosure of the study information | 2006/09/01 |
| Last modified on | 2010/10/27 13:02:00 |
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Basic information
Public title
Therapeutic strategy of relative hypoparathyroidism in hemodialysis patients using sevelamer hydrochloride, with special reference to vitamin D administration
Acronym
The effect of sevelamer hydrochloride on relative hypoparathyroidism in hemodialysis patients
Scientific Title
Therapeutic strategy of relative hypoparathyroidism in hemodialysis patients using sevelamer hydrochloride, with special reference to vitamin D administration
Scientific Title:Acronym
The effect of sevelamer hydrochloride on relative hypoparathyroidism in hemodialysis patients
Region
| Japan |
Condition
Condition
Relative hypoparathyoidism in maintenance hemodialysis patients
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of decreasing the calcium load by sevelamer hydrochloride on mineral and bone metabolism in hemodialysis patients with relative hypoparathyroidism, with or wtihout vitamin D administration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in serum levels of calcium, phosphate, parathyroid hormone, and bone metabolism markers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Replacement of calcium carbonate with sevelamer hydrochloride as phosphate binder
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Maintenance hemodialysis patients with intact-PTH of 150 pg/ml or less, and receiving calcium carbonate alone as phosphate binder
Key exclusion criteria
Hospitalized or medically unstable patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Inoue |
Organization
Osaka Medical College
Division name
Blood Purification Center
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Inoue |
Organization
Osaka Medical College
Division name
Blood Purification Center
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
t-inoue@poh.osaka-med.ac.jp
Sponsor or person
Institute
Hokusetsu ROD Study Group
Institute
Department
Personal name
Funding Source
Organization
Blood Purification Center, Osaka Medical College
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
NO
Study ID_1
Org. issuing International ID_1
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 | 09 | 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
Sevelamer hydrochloride has been expected to control hyperphosphatemia without calcium load. In this study, we investigated the effects of attenuation of calcium load by sevelamer hydrochloride on bone metabolic markers in 46 hemodialysis patients with serum intact parathyroid hormone (iPTH) levels < 150 pg/mL. After replacement of calcium carbonate with sevelamer, their serum calcium levels decreased. The iPTH levels increased after 4 weeks and the magnitude of the increase was significantly correlated with the extent of decrease in serum calcium concentration. The whole PTH, bone alkaline phosphatase (BAP), and bone-specific tartrate-resistant acid phosphatase (TRAP5b) levels were also increased after 12 weeks. However, the relationship between iPTH and BAP or TRAP5b which was observed before the sevelamer replacement therapy was preserved only in the patients with serum iPTH levels < 60 pg/mL at enrollment. Thus, in the patients with pretreatment iPTH levels >= 60 and < 150 pg/mL, the increase in iPTH level might not always result in the improvement of bone metabolism. In the patients administered with vitamin D at enrollment, the frequency of overshooting of iPTH, BAP, or TRAP5b was lower than that in the patients without vitamin D administration. In conclusion, replacing calcium carbonate with sevelamer could be a therapeutic option in the patients with hypoparathyroidism (iPTH < 60 pg/mL) to improve bone metabolism and vitamin D might be useful to avoid the excess enhancement of bone turnover by sevelamer therapy.
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
| 2006 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 08 | Month | 21 | Day |
Last modified on
| 2010 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000495
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