UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008914
Receipt number R000010455
Scientific Title Comparison of spironolactone and trichlormethiazide as add-on therapy to renin-angiotensin blockade for reduction of albuminuria in diabetic patients
Date of disclosure of the study information 2012/09/13
Last modified on 2012/09/13 21:32:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Comparison of spironolactone and trichlormethiazide as add-on therapy to renin-angiotensin blockade for reduction of albuminuria in diabetic patients

Acronym

Spironolactone and thiazide in patients with diabetic nephropathy

Scientific Title

Comparison of spironolactone and trichlormethiazide as add-on therapy to renin-angiotensin blockade for reduction of albuminuria in diabetic patients

Scientific Title:Acronym

Spironolactone and thiazide in patients with diabetic nephropathy

Region

Japan


Condition

Condition

Diabetic patients with persistent albuminuria

Classification by specialty

Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of spironolactone versus trichlormethiazide on changes in albuminuria, when either is used as add-on therapy to an ACE inhibitor or ARB in diabetic patients with CKD

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in albuminuria at 24 weeks of treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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

Oral administration of spironolactone (25 mg/day)

Interventions/Control_2

Oral administration of trichlormethiazide (2 mg/day)

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

40 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Japanese type 2 diabetic patients with urinary albumin-to-creatinine ratio (ACR) from first morning urine &#8805; 100 mg/g and use of an ACE inhibitor or ARB for at least 6 months.

Key exclusion criteria

Patients with clinically significant heart, liver, infectious, or malignant disease, those with serum creatinine was &#8805; 2.0 mg/dL, or those with serum potassium was &#8805; 5.0 mEq/L or < 3.5 mEq/L.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Babazono

Organization

Tokyo Women's Medial University School of Medicine

Division name

Diabetes Center

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-8111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Tetsuya Babazono

Organization

Tokyo Women's Medial University School of Medicine

Division name

Diabetes Center

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-8111

Homepage URL


Email



Sponsor or person

Institute

Diabetes Center, Tokyo Women's Medial University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Diabetes Center, Tokyo Women's Medial University School of Medicine

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

東京女子医科大学糖尿病センター


Other administrative information

Date of disclosure of the study information

2012 Year 09 Month 13 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

2001 Year 09 Month 30 Day

Date of IRB


Anticipated trial start date

2001 Year 10 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 09 Month 13 Day

Last modified on

2012 Year 09 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010455


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name