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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001052
Receipt No. R000001182
Scientific Title Prospective randomized study of tolerability and efficacy of combination therapy on chronic kidney disease
Date of disclosure of the study information 2008/02/26
Last modified on 2014/02/25

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Basic information
Public title Prospective randomized study of tolerability and efficacy of combination therapy on chronic kidney disease
Acronym PROTECT-CKD Study
Scientific Title Prospective randomized study of tolerability and efficacy of combination therapy on chronic kidney disease
Scientific Title:Acronym PROTECT-CKD Study
Region
Japan

Condition
Condition Chronic kidney diseases
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the patients with chronic kidney disease associated with hypertension, the effects of combination of losartan and low dose of hydrochlorochiazide, combination of losartan and enalapril, and combination of kosartan and amlodipine on blood pressure and urinary excretion of protein or albumin are compared. In addition, achievement rate of goal blood pressure, tolerability, and the effects on metabolism are observed.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure changes at 4 months after the start of combination therapy
Key secondary outcomes Changes in systolic blood pressure at 4 months after the start of combination therapy
Rates of systolic blood pressure change and achievement of goal systolic blood pressure at 4 months after the start of combination therapy
Rates of changes in urinary excretion of protein or albumin at 4 months after the start of combination therapy
Rates and values of systolic blood pressure at 12 months after the start of combination therapy
Rates of changes in urinary excretion of protein or albumin at 12 months after the start of combination therapy
Changes in eGFR values at 12 months after the start of combination therapy
Rates of achievement of goal blood pressure 12 months after the start of combination therapy
Changes in HOMA-R
Safety of the drugs throughout the study period

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Loosartan and hydrochlorothiazide group
Interventions/Control_2 Loosartan and enalapril group
Interventions/Control_3 Loosartan and amlodipine group
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) At 2 months after the therapy with 50 mg of losartan, systolic blood pressure is more than 130 mmHg and/or diastolic blood pressure is more than 80 mmHg.
2) Outpatients only
3) Written informed consent is required.
Key exclusion criteria 1) Diastolic blood pressure is more than 120 mmHg.
2) HbA1cis more than 8.0%.
3) The occurrence of acute myocardial infarction, stroke, and the other vascular diseases within 6 months.
4) The patients who require calcium blocker for ischemic heart disease.
5) The patients with heart failure whose grade is more than NYHA III.
6) The patients with gout or hyperuricemia, which is more than 8.0 mg/dl at the start of the study.
7) Serum creatinine is more than 2.5 mg/dl.
8) AST or ALT is more than three-time of normal upper level
9) Bilateral renal artery stenosis
10) Endocrinological secondary hypertension
11) Autosomal dominant polycystic kidney disease, congenital anomaly of the kidney, unilateral agenesis of the kidney
12) Malignant hypertension
13) Possible or definite case of pregnancy, lactating women
14) The patients with the history of drug allergy to the study drugs.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiko Iino
Organization Nippon Medical School
Division name Division of Nephrology
Zip code
Address 1-1-5 Sendagi, bunkyo-ku, Tokyo, 113-8602
TEL 03-3822-2131
Email iinoyasuhiko@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Matsuhiko Hayashi
Organization Keio University, School of Medicine
Division name Department of Internal Medicien
Zip code
Address 35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582
TEL 03-5363-3796
Homepage URL
Email matuhiko@z3.keio.jp

Sponsor
Institute Kanto District CKD Treatment Study Group
Institute
Department

Funding Source
Organization The Kidney Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2008 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
2008 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 09 Month 01 Day
Date trial data considered complete
2013 Year 10 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 02 Month 25 Day
Last modified on
2014 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001182

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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