Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Avacopan

    Drug

    Avacopan is a complement 5a receptor (C5aR) antagonist, orally active.

  • Prednisone

    Drug

    0.4 mg/kg per day (maximum, 32 mg/day) for 2 months followed by dose tapering by 4 mg per day each month (total duration 6-9 months

  • Methylprednisolone (drug)

    Drug

    Methylprednisolone 1g intravenous on day +1

  • Prednisolone

    Drug

    Prednisone 0.2 mg/kg per day (maximum, 16 mg/day) for 2 months followed by dose tapering by 2 mg per day each month (total duration 6-9 months)

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Avacopan and Low Doses GlucocorticoidActive comparator 3 interventions
Group B: High Doses GlucocorticoidActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in proteinuria measured by results of protein total, 24-hour urine collection at baseline compared to collection at 12 months.

A response is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.

Time frame
12 months

Secondary outcomes

1

Change in proteinuria >50%

This is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.

Time frame
12 months
2

Change in eGFR (using 2021 CKD-EPI Formula)

• Change in eGFR (using 2021 CKD-EPI Formula) at 6 and 12 months compared to baseline

Time frame
6 months, 12 months
3

Change in hematuria from Baseline to 12 month visit.

Hematuria is measured in the urinalysis done at baseline and 12-month visit.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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