IgA Nephropathy (IgAN)Phase 2NCT06676579
Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
A Phase 2 study testing Avacopan, Prednisone and Methylprednisolone (drug) in people with IgA Nephropathy (IgAN), run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- Avacopan, Prednisone and Methylprednisolone (drug)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jun 2025to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Hematuria defined as >10 RBC/hpf or hemoglobinuria >1+
- Patients need to be in adequate supportive care (blood pressure <125/85mmHg, lifestyle advice, and maximum doses tolerable of RAS blockade) at least 4 weeks prior to enrollment
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- Patients would receive dietary and lifestyle counseling prior enrollment: low protein (0.8-1.0 g/kg/day) diet, low sodium (2 grams/day) intake, indication for smoke cessation, during the 4 weeks run-in period
- Has signed an informed consent form prior to any study-related procedures
- Patients with documented use of RAS blockade and adequate blood pressure control (<125/85 mmHg) for ≥4 weeks, can be enrolled in the study and randomized without repeating a 4-week run-in period.
Who cannot join
- 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)
- Women who are pregnant or breastfeeding
- Immunosuppression treatment:
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- Rituximab less than 12 months prior to enrollment
- MMF, CYC, or immunomodulatory agents within 3 months prior to enrollment
- AZA within 3 months prior to enrollment.
- Glucocorticoids >20 mg/day within 1 month prior to enrollment
- Secondary IgA nephropathy (associated with gastrointestinal diseases, infection, autoimmune, malignancy, respiratory tract, or skin)
- ANCA-associated vasculitis or other vasculitis diagnostic defined by ACR criteria/Chapel Hill Consensus conference
- Contraindication to use any of the protocol treatments (glucocorticoids, avacopan)
- Use of a strong/moderate CYP3A4 inducer
- Initiation of SGLT2 inhibitors is not allowed once patient has been enrolled in the study. Patients who have been on an SGLT2 inhibitor prior to enrollment on the study may continue on this therapy, at the same dose. No dose increase is allowed.
- Active, untreated and/or uncontrolled chronic liver disease (chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis, cirrhosis
- Unable to give written consent form
- As a safety measure patients who are pregnant or lactating will not be enrolled in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Nabeel Aslam
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Fernando Custodio Fervenza
About this study
Official title: A Multi-Center, Phase II, Open Label, Randomized Trial Evaluating the Efficacy and Safety of Complement 5a Receptor Antagonist Avacopan in Crescentic IgA Nephropathy
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.
- Conditions
- IgA Nephropathy (IgAN)
- Being tested
- Avacopan, Prednisone, Methylprednisolone (drug), Prednisolone
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvacopanDrug
Also called Tavneos
Avacopan is a complement 5a receptor (C5aR) antagonist, orally active.
PrednisoneDrug
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
PrednisoloneDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Avacopan and Low Doses Glucocorticoid | Active comparator | * 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 Receives: Drug: Avacopan; Drug: Methylprednisolone (drug); Drug: Prednisolone |
| High Doses Glucocorticoid | Active comparator | * 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) Receives: Drug: Prednisone; Drug: Methylprednisolone (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Change in proteinuria >50%
This is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.
Measured: 12 months
Change in eGFR (using 2021 CKD-EPI Formula)
- Change in eGFR (using 2021 CKD-EPI Formula) at 6 and 12 months compared to baseline
Measured: 6 months, 12 months
Change in hematuria from Baseline to 12 month visit.
Hematuria is measured in the urinalysis done at baseline and 12-month visit.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start9 Jun 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Fervenza, Mayo Clinic
- Investigators
- Fernando Fervenza, MD, Principal investigator, Mayo Clinic, Rochester, MNNabeel Aslam, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676579
- Sponsor's protocol ID
- 24-005668
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Phase II, Open Label, Randomized Trial Evaluating the Efficacy and Safety of Complement 5a Receptor Antagonist Avacopan in Crescentic IgA Nephropathy
- ClinicalTrials.gov ID
- NCT06676579
- Acronym / sponsor ID
- 24-005668
- Conditions
- IgA Nephropathy (IgAN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avacopan and Low Doses Glucocorticoid | Active comparator | Drug: Avacopan, Drug: Methylprednisolone (drug), Drug: 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 | Active comparator | Drug: Prednisone, Drug: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Hematuria defined as >10 RBC/hpf or hemoglobinuria >1+
Key exclusion criteria (18 listed)
- 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)
- Women who are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvacopanAlso: TavneosAvacopan is a complement 5a receptor (C5aR) antagonist, orally active. | Drug | Avacopan and Low Doses Glucocorticoid |
| Prednisone0.4 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 | Drug | High Doses Glucocorticoid |
| Methylprednisolone (drug)Methylprednisolone 1g intravenous on day +1 | Drug | Avacopan and Low Doses Glucocorticoid, High Doses Glucocorticoid |
| PrednisolonePrednisone 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) | Drug | Avacopan and Low Doses Glucocorticoid |
Primary outcome
Change in proteinuria measured by results of protein total, 24-hour urine collection at baseline compared to collection at 12 months.
Time frame: 12 months
A response is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.
3 secondary outcomes
Change in proteinuria >50%
Time frame: 12 months
Change in eGFR (using 2021 CKD-EPI Formula)
Time frame: 6 months, 12 months
Change in hematuria from Baseline to 12 month visit.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando Fervenza, MD principal investigator
Mayo Clinic, Rochester, MN
Nabeel Aslam, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avacopan, Prednisone and Methylprednisolone (drug) in people with IgA Nephropathy (IgAN), run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corbyn Bendtsen (507-284-0366, bendtsen.corbyn@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proteinuria measured by results of protein total, 24-hour urine collection at baseline compared to collection at 12 months. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.