UnknownPhase 4

A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy

Japan30 participantsStarted 2010-06

Plain-language summary

The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA nephropathy.

Who can participate

Age range

16 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Renal function (Creatinine clearance)

Timeframe: One year (every 6 months)

Urinary protein

Timeframe: One year (every 6 months)

Trial details

NCT IDNCT01184599

SponsorKagawa University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-03

Contact for this trial

Masahito Imanishi

+81-6-6929-1221 masachan@msic.med.osaka-cu.ac.jp

View on ClinicalTrials.gov More Glomerulonephritis, IGA trials

Who can participate

Age range

16 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.