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New treatment option for IgA Nephropathy (IgAN)
Official title Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
ClinicalTrials.gov ID: NCT06676579
What this study is testing
What is Avacopan?
Avacopan is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for iga nephropathy (igan).
Also referred to as Tavneos.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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+
You likely can't join if
- 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...
- 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:
See the full eligibility criteria
- 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
- 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 assigned by chance without repeating a 4-week run-in period.
- 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:
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.