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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAir Force Military Medical University, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prednisolone

    Drug

    RAS blockade as much as tolerated or allowed

  • Prednisolone plus Cyclophosphamide

    Drug

    RAS blockade as much as tolerated or allowed

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: CSActive comparator 1 intervention
Group B: CS+CTXActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Combined event

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

Time frame
up to 6 years

Secondary outcomes

1

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

Proteinuria remission

Time frame
up to 6 years
2

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

Hematuria remission

Time frame
up to 6 years
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

Other outcomes

Sponsors and contacts

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