UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001656
Receipt number R000001997
Scientific Title Evaluation of efficacy and safety of active vitamin D treatment for secondary hyperparathyroidism in patients on maintenance hemodialysis; competitive study
Date of disclosure of the study information 2009/01/25
Last modified on 2014/09/29 14:37:40

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Basic information

Public title

Evaluation of efficacy and safety of active vitamin D treatment for secondary hyperparathyroidism in patients on maintenance hemodialysis; competitive study

Acronym

Randomized clinical trial with alfacalcidol versus maxacalcitol

Scientific Title

Evaluation of efficacy and safety of active vitamin D treatment for secondary hyperparathyroidism in patients on maintenance hemodialysis; competitive study

Scientific Title:Acronym

Randomized clinical trial with alfacalcidol versus maxacalcitol

Region

Japan


Condition

Condition

secondary hyperparathyroidism(SHPT)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of study is to evaluate the effect of differential active vitamin D (alfacalcidol versus maxacalcitol) for SHPT in patients on maintenance hemodialysis(MHD).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The percentage achievement of recommendation value (60-180pg/mL) of intact parathyroid hormone(PTH).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

affacalcidol

Interventions/Control_2

maxacalcitol

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Renal dysfunction: end-stage chronic kidney disease, require maintenance dialysis due to renal dysfunction
2) Expected survival time is more than 6 months
3)Fully informed consent was obtained
4)Intact PTH level 180pg/mL-500pg/mL
5)Serum P level 3.5-7.0mg/dL
6)Serum adjusted Ca 8.4-10.5mg/dL

Key exclusion criteria

1) Malignancy,malnutrition, active inflammatory or infectious disease
2)Severe heart failure and liver dysfunction
3)Pregnancy, during breast-feeding
4)Patients with allergy to affacalcidol and maxacalcitol
5)Primary hyperparathyroidism patients
6)Aluminum and Fe associated bone disease patients
7)Post parathyroidectomy patients, patients received percutaneous ethanol or vitamin D injection
8) Judged inappropriate for this study by the physicians
9)Parients who were recruited another clinical trial within 3 months

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirokazu Honda

Organization

Showa University School of Medicine

Division name

Division of Nephrology , Department of Medicine

Zip code


Address

1-5-8, Hatanodai, Shinagawaku, Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Showa University Showa University School of Medicine

Division name

Division of Nephrology Department of Medicine

Zip code


Address


TEL


Homepage URL


Email

hondah@med.showa-u.ac.jp


Sponsor or person

Institute

Division of Nephrology Department of Medicine Showa University School of Medicin

Institute

Department

Personal name



Funding Source

Organization

Division of Nephrology Department of Medicine Showa University School of Medicin

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


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



Other administrative information

Date of disclosure of the study information

2009 Year 01 Month 25 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

Completed

Date of protocol fixation

2008 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 06 Month 01 Day

Last follow-up date

2010 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2013 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2009 Year 01 Month 25 Day

Last modified on

2014 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001997


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name