Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)

Phase 2

Not yet recruiting

• Conditions: IgA Nephropathy (IgAN)
• Interventions: Drug: Prednisone; Drug: Avacopan; Drug: Methylprednisolone (drug); Drug: Prednisolone

• Registration Number: NCT06676579
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-06
• Last Update Posted: 2024-11-06
• Study Start: 2024-12-02
• Primary Completion: 2027-12-02
• Study Completion: 2028-12-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avacopan and Low Doses Glucocorticoid	Methylprednisolone (drug)	* 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
Avacopan and Low Doses Glucocorticoid	Prednisolone	* 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
High Doses Glucocorticoid	Prednisone	* 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)
High Doses Glucocorticoid	Methylprednisolone (drug)	* 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)
Avacopan and Low Doses Glucocorticoid	Avacopan	* 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

Primary Outcome Measures

Name	Time	Method
Change in proteinuria measured by results of protein total, 24-hour urine collection at baseline compared to collection at 12 months.	12 months	A response is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.

Secondary Outcome Measures

Name	Time	Method
Change in proteinuria >50%	12 months	This is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.
Change in eGFR (using 2021 CKD-EPI Formula)	6 months, 12 months	• Change in eGFR (using 2021 CKD-EPI Formula) at 6 and 12 months compared to baseline
Change in hematuria from Baseline to 12 month visit.	12 months	Hematuria is measured in the urinalysis done at baseline and 12-month visit.

Trial Locations

Locations (2)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States