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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002776
Receipt No. R000003378
Scientific Title Randomized, controlled trial of the effect of short-term co-administration of methylcobalamin and folate on serum asymmetric dimethylarginine (ADMA) concentration in patients receiving long-term hemodialysis.
Date of disclosure of the study information 2009/11/17
Last modified on 2009/11/17

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Basic information
Public title Randomized, controlled trial of the effect of short-term co-administration of methylcobalamin and folate on serum asymmetric dimethylarginine (ADMA) concentration in patients receiving long-term hemodialysis.
Acronym Randomized, controlled trial of the effect of short-term co-administration of methylcobalamin and folate on serum ADMA concentration.
Scientific Title Randomized, controlled trial of the effect of short-term co-administration of methylcobalamin and folate on serum asymmetric dimethylarginine (ADMA) concentration in patients receiving long-term hemodialysis.
Scientific Title:Acronym Randomized, controlled trial of the effect of short-term co-administration of methylcobalamin and folate on serum ADMA concentration.
Region
Japan

Condition
Condition Chronic kidney disease (CKD)
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of the current study is to investigate whether, in patients receiving long-term hemodialysis, combined administration of oral folate and intravenous methylcobalamin is more beneficial than oral folate alone at reducing the circulating level of ADMA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Our primary endpoint was the effect of co-administration of intravenous methylcobalamin and oral folate versus that of oral folate alone as regards normalization of plasma homocysteine (<15 micro mol/L) and reduction of serum ADMA in hemodialysis patients.
Key secondary outcomes Secondary outcomes were the changes in the augmentation index and in the ratios of S-adenosylmethionine (SAM) to S-adenosylhomocysteine (SAH) as a transmethylation indicator and dimethylamine (DMA) to ADMA and dimethylamine to ADMA as an ADMA-hydrolysis indicator.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Patients who received supplementation with folate alone (15 mg/day) for 3 weeks.
Interventions/Control_2 Patients who received supplementation with oral folate (15 mg/day) together with intravenous methylcobalamin (500 micro g after each hemodialysis session, 3 times/week) for 3 weeks.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with established end-stage renal disease undergoing maintenance hemodialysis in Kariya-Toyota General Hospital.
Key exclusion criteria Exclusion criteria for this study were as follows: (1) severe anemia (hematocrit <25%), (2) diabetes mellitus, (3) evident infectious or inflammatory diseases, (4) malignant diseases, (5) homocystinuria, (6) smoking habit, (7) atherosclerosis obliterans, (8) left ventricular systolic dysfunction (ejection fraction <50%), (9) liver dysfunction, (10) specific indication for, or contraindication to, the study-drugs or study-procedures, (11) malnutrition [i.e., patients exhibiting subjective global nutritional assessment (SGA) score B or C] during the study period.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsushi Koyama
Organization Kariya-Toyota General Hospital
Division name Department of Nephrology
Zip code
Address 5-15 Sumiyoshi-cho, Kariya 448-8505, Japan
TEL +81-566-21-2450
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsushi Koyama
Organization Kariya-Toyota General Hospital
Division name Department of Nephrology
Zip code
Address 5-15 Sumiyoshi-cho, Kariya 448-8505, Japan
TEL +81-566-21-2450
Homepage URL
Email nephkidedta@do9.enjoy.ne.jp

Sponsor
Institute Department of Nephrology, Kariya-Toyota General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Pharmacology, Department of Cardio-Renal Medicine and Hypertension, Graduate School of Medical Sciences, Nagoya City University
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 刈谷豊田総合病院 (愛知県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 17 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
2004 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 06 Month 01 Day
Last follow-up date
2004 Year 10 Month 01 Day
Date of closure to data entry
2009 Year 05 Month 01 Day
Date trial data considered complete
2009 Year 05 Month 01 Day
Date analysis concluded
2009 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 17 Day
Last modified on
2009 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003378

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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