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Search / Trial NCT03468972

Effect of Immunosuppression in IgA Nephropathy

Launched by YONSEI UNIVERSITY · Mar 12, 2018

Trial Information

Current as of May 29, 2025

Unknown status

Keywords

Ig A Nephropathy Immunosuppression

ClinConnect Summary

The investigators will conduct a multicenter prospective randomized controlled open-label trial; a step-wise therapeutic approach in IgAN patients with persistent proteinuria who have preserved eGFR of ≥ 30 ml/min/1.73 m2. During 3-6 months before the enrollment, all patients will receive maximal supportive care including the use of RAS blockers, blood pressure control with a target of \<130/80 mmHg, and protein restriction diet. If proteinuria does not decrease \< 1.0 g/g creatinine, patients will be randomly assigned to continue supportive care, or to receive corticosteroids. At 3 months ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Biopsy-proven IgA nephropathy within 5 years of enrollment
  • Persistent proteinuria of UPCR ≥ 1.0 g/g creatinine during 12-week supportive care including RAS blockers
  • baseline eGFR ≥ 30 ml/min/1.73 m2 assessed by CKD-EPI equation
  • Exclusion Criteria:
  • Nephrotic syndrome, atypical IgA nephropathy
  • Crescents ≥ 25%
  • Overt pulmonary tuberculosis
  • Malignancy within 5 years of enrollment
  • Pregnancy or breast feeding
  • Active hepatitis, chronic hepatitis, liver cirrhosis, HIV
  • Kidney transplant
  • Current use of immunosuppressive treatment or prior use of immunosuppressive drugs within 1 year of enrollment
  • Uncontrolled hypertension (\> 160/100 mmHg)
  • Aged \< 19 years
  • Secondary IgA nephropathy such as lupus nephritis, chronic liver disease, or Henoch-Schlein purpura
  • Involvement of other clinical trials within 3 months of enrollment

About Yonsei University

Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.

Locations

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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