Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00027

2 Trial Registration Date

2005-09-06

i Registration Status

Retrospective

3 Secondary IDs

CRE-2002.376.T

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

n/a

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. SZETO Cheuk Chun

ii Address

Department of Medicine & Therapeutics, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

85226323146

iv Email

ccszeto@cuhk.edu.hk

v Affiliation

Department of Medicine & Therapeutics, CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. SZETO Cheuk Chun

ii Address

Department of Medicine & Therapeutics, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

85226323126

iv Email

ccszeto@cuhk.edu.hk

v Affiliation

Department of Medicine & Therapeutics, CUHK

vi Country

9 Official Scientific Title of the Study

Treatment of Early Immunoglobulin A Nephropathy by the Angiotensin Converting Enzyme Inhibitor Ramipril - A Randomized Controlled Trial

10 Public Title

Treatment of Early Immunoglobulin A Nephropathy by the Angiotensin Converting Enzyme Inhibitor Ramipril - A Randomized Controlled Trial

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Ramipril for early IgAN

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2002-11-06

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

IgA nephropathy

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

ramipril

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

5 years

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

no treatment

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria are: • age between 18 and 65 • biopsy-confirmed IgA nephropathy • proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 Ýmol/l • willingness to give written informed consent and willingness to participate in and comply with the study protocol

ii Exclusion Criteria

Exclusion criteria are: • expected survival less than 2 years • pregnant or nursing mother, or women of childbearing potential without an effective method of birth control • history of myocardial infarction, congestive heart failure, or any other medical indication that necessitate the use of ACE inhibitor • evidence of clinically significant hepatic, gastrointestinal, autoimmune disease • history of malignancy, drug or alcohol abuse • participation in any previous trial on ACE inhibitor • taking other investigational drugs within the past 30 days • history of non-compliance to medical regimens and patients who are considered potentially unreliable • known history of sensitivity / allergy to ACE inhibitor

iii Age Minimum

18

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2004-01-01

21 Target Sample Size

60

22 Recruitment Status

Complete

23 Primary Outcome

• development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy) • development of proteinuria d 1 g per day • 20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation

24 Secondary Outcome

n/a

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-01

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000630

28 Date of Registration in Primary Registry

2010-05-04

Back History

Trial Detail