Rituximab in Recurrent IgA Nephropathy (NCT02571842) | Clinical Trial Compass
UnknownPhase 4
Rituximab in Recurrent IgA Nephropathy
Thailand30 participantsStarted 2012-01
Plain-language summary
Currently, the treatment options of recurrent IgA nephropathy (IgAN) are conflicting and largely based on expert opinions. Consequently, the recent KDIGO clinical practice guideline for the care of kidney transplant recipients has concluded that there are no definite strategies for prevention and treatment. However, recurrent IgAN in the transplanted kidney is common and may contribute to graft loss, in particular, if cresentic formation, extra- or endocapillary proliferation were presented in kidney pathology. Herein, the investigators assume that rituximab, anti-CD20 Ab agent, can reduce circulating IgA with subsequently decrease rate of polymeric forms of IgA deposition in glomerular capillaries. Therefore, the investigators speculate that rituximab may have potential effect to reduce circulating polymeric forms of IgA and slow progression of recurrent IgAN.
Who can participate
Age range
18 Years – 70 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:
* Any kidney transplant recipients between the age of 18 and 70 years of age and able to give informed consent
* GFR by 24h Creatinine Clearance (CrCl) \>30 ml/min/1.73m²
* Biopsy proven recurrent IgA nephropathy with endocapillary proliferation pattern
Exclusion Criteria:
* Clinical and histologic evidence of IgA combination with other forms of glomerulonephritis
* Clinical evidence of cirrhosis, chronic active liver disease or known infection with hepatitis B, C or HIV
* 24h CrCl \<30 ml/min/1.73m² at the time of screening
* Active systemic infection or history of serious infection within one month of entry
* Positive pregnancy test or breast feeding at time of study entry
* Patients receiving \>6 months therapy with oral prednisone \>5mg/day or glucocorticoid equivalent
* Live vaccine within 28 days of study enrollment.
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.