Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

This study will compare a short-term course (12 week) glucocorticoid regimen with the Conventional 24-week regimen as originally proposed by KDIGO. The purpose of the study is to determine a short-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive nephrotic syndrome.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Urine protein: creatinine ratio ≥3000mg/g (300mg/mmol)

Serum/plasma albumin level < 30g/L

Age ≥ 16 years at the time of diagnosis

No prior therapy with steroids, immunosuppressive or cytotoxic agents for any form of renal disease (other than the 28 days of prednisolone therapy given initially as routine clinical practice)

Disqualifiers

Secondary nephrotic syndrome

Contradictions for glucocorticoids

SRNS: Lack of complete remission within 4 weeks of therapy with daily prednisone or prednisolone at standard dose

anti-PLA2R positive

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional 24-week glucocorticoid regimen

    Drug

    Weeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5 - 6: Prednisolone 0.8mg/kg/day (max 60mg); Weeks 7 - 8: Prednisolone 0.6mg/kg/day (max 50mg); Weeks 9 - 10: Prednisolone 0.5mg/kg/day (max 40mg); Weeks 11 - 12: Prednisolone 0.4mg/kg/day (max 30mg); Weeks 13 - 16: Prednisolone 0.3mg/kg/day (max 25mg); Weeks 17 - 20: Prednisolone 0.2mg/kg/day (max 15 Weeks 21 - 24: Prednisolone 0.1mg/kg/day (max 10mg).

  • short-term course (12 week) glucocorticoid regimen

    Drug

    Weeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5-8: Prednisolone 1mg/kg/day (max 80mg) on alternate days; 9-12: Prednisolone 0.5mg/kg/day (max 40mg) on alternate days

Treatment groups

224 Participants
are divided into 2 treatment groups
Group A: conventional course prednisolone armActive comparator 1 intervention
Group B: short-term course prednisolone armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Relapse

Relapse of proteinuria is defined by Albustix positive proteinuria (+++ or greater) for 3 consecutive days or the presence of generalised oedema plus 3+ proteinuria.

Time frame
through study completion, an average of 2 years

Secondary outcomes

1

Relapse rate

the proportion of adults who develop relapsing

Time frame
12 months,24 months

Other outcomes

Sponsors and contacts

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