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

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

Treatments tested in this trial

  • Conventional 24-week glucocorticoid regimen
  • short-term course (12 week) glucocorticoid regimen

Treatment groups

224 Participants
are divided into 2 treatment groups