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Recruitment status Completed
Unique ID issued by UMIN UMIN000000835
Receipt No. 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

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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
Email

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
Email sfukumoto@med.osaka-cu.ac.jp

Sponsor
Institute Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine
Institute
Department

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
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
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 &#8805;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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001004

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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