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Corticosteroid

Avacopan for IgA Nephropathy

Phase 2

Waitlist Available

Led By Fernando Fervenza, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Severe interstitial fibrosis and tubular atrophy (IFTA > 70% on renal biopsy)

Active cancer or acute non-controlled infection (including HIV, HBV, HCV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if using Avacopan along with low-dose glucocorticoid is effective and safe in treating patients with a certain type of kidney disease called crescentic Immunoglob

Who is the study for?

This trial is for patients with a severe form of kidney disease known as crescentic IgA Nephropathy, which has a high risk of getting worse. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.

What is being tested?

The trial is testing the effectiveness and safety of Avacopan when used alongside low doses of glucocorticoids (steroid medications) in treating crescentic IgA Nephropathy. The comparison might involve standard treatments such as Prednisone, Methylprednisolone, or Prednisolone.

What are the potential side effects?

Possible side effects from Avacopan and glucocorticoids can include increased infection risk, changes in blood sugar levels, mood swings, weight gain, bone weakening (osteoporosis), high blood pressure, and stomach ulcers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is good, with a creatinine clearance rate above 20 ml/min.

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My 24-hour urine test shows high protein levels despite medication.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney biopsy shows severe damage.

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I do not have an active cancer or uncontrolled infection.

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I am not pregnant or breastfeeding.

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I am not pregnant or breastfeeding.

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My kidney disease is related to another health condition.

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I am taking medication that strongly affects liver enzyme levels.

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My liver tests are more than twice the normal limit.

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I have been diagnosed with ANCA-associated vasculitis or another type of vasculitis.

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I cannot take certain medications like glucocorticoids or avacopan due to health reasons.

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I do not have active, untreated liver disease or cirrhosis.

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I haven't taken strong immune system medications recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in eGFR (using 2021 CKD-EPI Formula)

Change in hematuria from Baseline to 12 month visit.

Change in proteinuria >50%

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Avacopan and Low Doses GlucocorticoidActive Control3 Interventions

* Methylprednisolone 1g intravenous on day +1 * 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) * Avacopan 30 mg oral twice a day (1-0-1) for 12 months

Group II: High Doses GlucocorticoidActive Control2 Interventions

* Methylprednisolone 1g intravenous on day +1 * Prednisone 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)

0 / 14Eligibility criteria met