UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003236 |
|---|---|
| Receipt number | R000003912 |
| Scientific Title | Cinacalcet for the treatment of hypercalcemia with persistent hyperparathyroidism in renal transplant recipients: a case siries study. |
| Date of disclosure of the study information | 2010/02/26 |
| Last modified on | 2018/12/18 08:22:50 |
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Basic information
Public title
Cinacalcet for the treatment of hypercalcemia with persistent hyperparathyroidism in renal transplant recipients: a case siries study.
Acronym
Cinacalcet for the treatment of hypercalcemia with persistent hyperparathyroidism in renal transplant recipients: a case siries study.
Scientific Title
Cinacalcet for the treatment of hypercalcemia with persistent hyperparathyroidism in renal transplant recipients: a case siries study.
Scientific Title:Acronym
Cinacalcet for the treatment of hypercalcemia with persistent hyperparathyroidism in renal transplant recipients: a case siries study.
Region
| Japan |
Condition
Condition
Hypercalcemia with persistent hyperparathyroidism in renal transplant recipients.
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of cinacalcet for hypercalcemia with persistent hyperparathyroidism after renal transplantation by bone-mineral biomarkers and imaging studies of parathyroid glands.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Absolute or relative changes in serum calcium, phosphate and intact-PTH levels.
Key secondary outcomes
Absolute or relative changes of parathyroid grands size, bone density, vascular stiffness and bone metabolism markers (vitamin D, FGF23) and safety evaluations (by kidney function, interaction with immunosuppressives)
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
Cinacalcet Hydrochloride
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
1.kidney transplant recipient(living or cadaver) at least 6 months after transplantation.
2.Persistent hyperparathyroidism with hypercalcemia [serum intact-PTH greater than 65 pg/ml and corrected serum calcium concentration greater than 10.3 mg/dl by Payne equation cCa = (4- measured albumin)+measured calcium].
3.Stable kidney function with eGFR greater than 30 ml/min/1.73m2 over the last 3 months.
4.No need for change in doses of maintenance immunosuppressive therapy over the last 3 months within target trough levels.
(Cyclosporine:trough 50-150 ng/ml, Tacrolimus:trough 5-10 ng/ml)
5.Agreed to verbal and written informed concent.
Key exclusion criteria
1.age below 20 years old or pregnant
2.those who cannot agree to the study
3.inappropriate patients judged by primary or study physicians.
4.history of allergy or severe side effects by cinacalcet
5.those with severe liver dysfunction
6.concomitant use of vitamin D sterols, phosphate binder, calcium supplementation, bisphosphonates
within 2 weeks before start of the study
7.history of parathyroidectomy or percutaneous ethanol injection therapy to parathyroid glands.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yugo Shibagaki |
Organization
St Marianna University
Division name
Nephrology and Hypertension
Zip code
Address
2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
TEL
044-977-8111
yugoshibagaki@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Yazawa |
Organization
St Marianna University
Division name
Nephrology and Hypertension
Zip code
Address
2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
TEL
044-977-8111
Homepage URL
masahikoyazawa@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna University
Institute
Department
Personal name
Funding Source
Organization
St Marianna University
Organization
Division
Category of Funding Organization
Other
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
聖マリアンア医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 22 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003912
