Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
ConditionIgA Nephropathy (IgAN)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The purpose of this study is to evaluate the efficacy and safety of Avacopan together with low-dose glucocorticoid in the treatment of patients with crescentic Imunoglobulin A Nephropathy (IgAN) and high risk of progression.
Eligibility criteria
Qualifiers
Age > 18 years
Kidney biopsy showing crescentic IgA nephropathy within 6 months of enrolment (MEST-C-score =C1/C2).
Quantified creatinine clearance >20 ml/min/1.73m2
Quantified Proteinuria > 750 mg/24h based on a 24h urine collection while on maximum tolerated dose of RAS blockade
Disqualifiers
Creatinine clearance <20 ml/min/1.73 m2
Liver function tests > 2x upper limit of normal. (Serious cases of hepatotoxicity have been reported in patients with avacopan during first approval and ADVOCATE study (29) (30)
Severe interstitial fibrosis and tubular atrophy (IFTA > 70% on renal biopsy)
Active cancer or acute non-controlled infection (including HIV, HBV, HCV)
Trial design
Treatments tested in this trial
- Avacopan
- Prednisone
- Methylprednisolone (drug)
- Prednisolone
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov