UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cinacalcet for the treatment of hypercalcemia with persistent hyperparathyroidism in renal transplant recipients: a case siries study.
Title of the study (Brief title)	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	Yugo Shibagaki
Organization	St Marianna University
Division name	Nephrology and Hypertension
Address	2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
TEL	044-977-8111
Email	yugoshibagaki@gmail.com

Public contact
Name of contact person	Masahiko Yazawa
Organization	St Marianna University
Division name	Nephrology and Hypertension
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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