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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003236
Receipt No. 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

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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
Email 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
Email masahikoyazawa@marianna-u.ac.jp

Sponsor
Institute St Marianna University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003912

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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