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NCT Number: NCT05510323

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

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.

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Key information

Conditions

Glomerulonephritis, IGA Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Indication or contraindication for immunosuppressive therapy with corticosteroids
  • Use of corticosteroids and other immunosuppressive drugs within the last 1 year
  • Current unstable kidney function for other reasons
  • Under 18 years old
  • Patients with secondary IgAN
  • Patients who are unlikely to comply with the study protocol in the view of the treating physician

Treatment and study plan

Prednisolone

Drug

RAS blockade as much as tolerated or allowed

Prednisolone plus Cyclophosphamide

Drug

RAS blockade as much as tolerated or allowed

Primary outcomes

  1. Combined event

    Time frame: up to 6 years

    40% decrease in eGFR, ESRD or death due to kidney disease

Secondary outcomes

  1. Proteinuria remission at 6, 12 months and total follow-up period

    Time frame: up to 6 years

    Proteinuria remission

  2. Hematuria remission at 6, 12 months and total follow-up period

    Time frame: up to 6 years

    Hematuria remission

  3. The composite of 30% decrease in eGFR, ESRD and all cause death

    Time frame: up to 6 years

  4. The composite of 40% decrease in eGFR, ESRD and all cause death

    Time frame: up to 6 years

  5. The composite of 50% decrease in eGFR, ESRD and all cause death

    Time frame: up to 6 years

  6. Annual eGFR decline rate

    Time frame: up to 6 years

  7. 30% decrease in eGFR

    Time frame: up to 6 years

  8. 40% decrease in eGFR

    Time frame: up to 6 years

  9. 50% decrease in eGFR

    Time frame: up to 6 years

  10. ESRD

    Time frame: up to 6 years

  11. All cause death

    Time frame: up to 6 years

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
Aug 22, 2022
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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