UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001052 |
|---|---|
| Receipt number | 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 11:10:33 |
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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
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
matuhiko@z3.keio.jp
Sponsor or person
Institute
Kanto District CKD Treatment Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001182
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