Fact CheckerSign in

NCT05510323RecruitingPhase 3

Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD

Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease

Source: ClinicalTrials.gov · Last updated 6 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal RAS inhibitor therapy, for IgA nephropathy with stage 3 or 4 chronic kidney disease.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
208 (estimated)
First submitted
18 Aug 2022
Start date
1 Feb 2024
Primary completion date
Aug 2025
Lead sponsor
Air Force Military Medical University, China
NCT number
NCT05510323

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 208
  • From 1 Feb 2024 to the primary completion date, Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Indication or contraindication for immunosuppressive therapy with corticosteroids
  • Use of corticosteroids and other immunosuppressive drugs within the last 1 year

Age

  • Under 18 years old

Other

  • Current unstable kidney function for other reasons
  • Patients with secondary IgAN
  • Patients who are unlikely to comply with the study protocol in the view of the treating physician

Who the study is looking for

  • Biopsy-proven IgA nephropathy;
  • Proteinuria ≥1.0g/day while receiving maximum tolerated dose of RAS blockade;
  • Estimated glomerular filtration rate 15-60 ml/min/1.73/m2.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AFMMU
Coordinator of this site? Confirm its status
Xi'anChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.