UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000835 |
|---|---|
| Receipt number | R000001004 |
| Scientific Title | Assesment for Responses to Cilnidipine in Diabetic Nephropathy with Hypertension |
| Date of disclosure of the study information | 2007/10/15 |
| Last modified on | 2012/10/15 09:29:45 |
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Basic information
Public title
Assesment for Responses to Cilnidipine in Diabetic Nephropathy with Hypertension
Acronym
Cilnidipine vs L-CCBs, Evaluation of Antihypertensive and Renoprotective Effects in Diabetic patients
(CLEARED study)
Scientific Title
Assesment for Responses to Cilnidipine in Diabetic Nephropathy with Hypertension
Scientific Title:Acronym
Cilnidipine vs L-CCBs, Evaluation of Antihypertensive and Renoprotective Effects in Diabetic patients
(CLEARED study)
Region
| Japan |
Condition
Condition
Diabetic nephropathy with hypertension
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the renoprotecrive and the antihypertensive effects of N/L type Ca-channel blocker (N/L-CCB; Cilnidipine) vs L type Ca-channel blocker (L-CCB; amlodipine, nifedipineCR, azelnidipine) in hypertensive patients with diabetic nephropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Change in urinary excretion of albumin or protein
2. Change in serum creatinin level or GFR
3. Blood pressure lowering effects.
Achievement of target blood pressure, <130/80 mmHg (<125/75 mmHg in case of more than 1g/day of urinary protein excretion)
Key secondary outcomes
Change in plasma glucose, HbA1C, insulin, total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol, urinary NAG excretion, or blood AGE levels, urinary BMG.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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
L-CCB/Cilnidipine group:
Switch to 6 month-treatment with cilnidipine after L-CCB administration for at least 6 months
Interventions/Control_2
Cilnidipine/L-CCB group:
Switch to 6 month-treatment with L-CCB after cilnidipine administration for at least 6 months
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with both conditions of (1) and (2).
(1) Hypertensive patients with diabetic nephropathy.
(2) Patients who need antihypertensive therapy with Ca-channel blocker.
Key exclusion criteria
(1) Contraindication to Ca-channel blocker
(2) The patient who is judged to be inappropriate for this study by the doctor in charge.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Fukumoto |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3806
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Fukumoto |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3806
Homepage URL
sfukumoto@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
non
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
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
| 2007 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0168822712000460
Number of participants that the trial has enrolled
Results
We evaluated the antialbuminuric advantage of cilnidipine, an N/L-type calcium channel blocker (CCB), compared with L-type CCBs in diabetic patients with normoalbuminuria and microalbuminuria. The study was a multicenter, non-randomized crossover trial. Participants were 90 type 2 diabetic patients exhibiting either normo- or microalbuminuria, and undergoing CCB treatment for ≥6 months prior to study entry. The CCB at the time of entry was continued for the first 6 months (Period 1). Treatment was subsequently switched from cilnidipine to an L-type CCB, or vice versa, for the second 6-month observation period (Period 2). During Period 1, the L-type CCB group showed a significant increase of urinary albumin excretion (UAE) over time, while the cilnidipine group showed no significant elevation. During Period 2, switching of the treatment from the L-type CCB to cilnidipine resulted in significant reduction of the UAE, whereas switching from cilnidipine to the L-type CCB resulted in no significant change in the UAE. This study demonstrated that the antialbuminuric effect of Cilnidipine, but not the L-type CCBs, was sustained even in patients treated for a long time. In addition, the antialbuminuric effect can be anticipated after switching from an L-type CCB to cilnidipine, but not vice versa.
(Diabetes Res Clin Pract. 2012 Jul;97(1):91-8. Epub 2012 Feb 13.)
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
| 2007 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 09 | Month | 27 | Day |
Last modified on
| 2012 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001004
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