ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT01184599
Date of registration:	16/08/2010
Prospective Registration:	No
Primary sponsor:	Kagawa University
Public title:	A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy
Scientific title:
Date of first enrolment:	June 2010
Target sample size:	30
Recruitment status:	Recruiting
URL:	http://clinicaltrials.gov/show/NCT01184599
Study type:	Interventional
Study design:	Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	Phase 4

Countries of recruitment
Japan

Contacts

Name:	Masahito Imanishi
Address:
Telephone:	+81-6-6929-1221
Email:	masachan@msic.med.osaka-cu.ac.jp
Affiliation:

Name:	Masahito Imanishi
Address:
Telephone:	+81-6-6929-1221
Email:	masachan@msic.med.osaka-cu.ac.jp
Affiliation:

Name:	Masahito Imanishi
Address:
Telephone:
Email:
Affiliation:	Osaka City General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- IgA nephropathy confirmed by renal biopsy

- Hypertension (<= 125/75 mmHg)

Exclusion Criteria:

- Patients who have been treated with angiotensin type 1 receptor blocker or
angiotensin-converting enzyme inhibitor within 4 weeks

- Severe hypertension (<= 180/110 mmHg) or secondary hypertension

- Patients with history of allergy or adverse effect for aliskiren

- Renal dysfunction (estimated Glomerular Filtration Rate < 60 mL/min/1.73m2)

- Pregnancy

- Patient treated with cyclosporine

- Hyperkalemia (serum potassium >= 5.6 mmol/L)

- Autoimmune disease including systemic lupus erythematosus

- Patients inadequate for the study

Age minimum: 16 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Glomerulonephritis, IGA

Hypertension

Intervention(s)

Drug: aliskiren

Primary Outcome(s)

Renal function (Creatinine clearance) [Time Frame: One year (every 6 months)]

Urinary protein [Time Frame: One year (every 6 months)]

Secondary Outcome(s)

Aldosterone [Time Frame: One year (every 12 months)]

(Pro)renin receptor [Time Frame: One year (every 12 months)]

High-sensitivity C-reactive protein [Time Frame: One year (every 6 months)]

Asymmetric dimethylarginine [Time Frame: One year (every 12 months)]

Advanced glycation end product [Time Frame: One year (every 12 months)]

Urinary angiotensinogen [Time Frame: One year (every 6 months)]

Oxidative stress [Time Frame: One year (every 12 months)]

Plasma Rennin Activity [Time Frame: One year (every 12 months)]

Urinary Transforming growth factor-beta [Time Frame: One year (every 6 months)]

Urinary type 4 collagen [Time Frame: One year (every 6 months)]

Secondary ID(s)

OCGH-746

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.