Povetacicept for IgA Nephropathy

Recruiting at 211 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Alpine Immune Sciences Inc, A Subsidiary of Vertex

Must be taking: ACEi, ARBs

Must not be taking: Immunosuppressives, Corticosteroids

Disqualifiers: Rapidly progressive glomerulonephritis, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.

Will I have to stop taking my current medications?

The trial requires that participants have a stable dose of certain blood pressure medications (ACE inhibitors or ARBs). If you are taking other medications, especially immunosuppressive treatments, you may need to stop them before joining the trial, but the protocol does not specify the exact details.

How is the drug Povetacicept different from other treatments for IgA nephropathy?

Povetacicept is a novel treatment option for IgA nephropathy, which is a condition with limited existing therapies. Unlike traditional treatments that focus on reducing proteinuria or using immunosuppressive agents, Povetacicept represents a new approach that may offer a more targeted intervention for this autoimmune kidney disease. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with IgA Nephropathy, confirmed by biopsy within the last 10 years. Participants must have significant protein in their urine and a minimum kidney function level. They should be on stable blood pressure medication like ACE inhibitors or ARBs.

Inclusion Criteria

Key

My daily protein loss in urine is high.

I was diagnosed with IgA nephropathy via biopsy in the last 10 years.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Povetacicept or placebo to evaluate efficacy in reducing proteinuria and preserving renal function

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Povetacicept (Monoclonal Antibodies)

Trial Overview The study tests Povetacicept's effectiveness against a placebo in reducing protein loss in urine and protecting kidney function among IgAN patients. It aims to see if this treatment can help manage the disease better than no active treatment.

Participant Groups

Group I: Povetacicept Experimental Treatment 1 Intervention

Participants will be randomized to receive Povetacicept.

Group II: Placebo Placebo Group 1 Intervention

Participants will be randomized to receive placebo matched to Povetacicept.

Who Is Running the Clinical Trial?

Alpine Immune Sciences Inc, A Subsidiary of Vertex

Lead Sponsor

Trials

1

Recruited

480+

Findings from Research

Recent studies indicate that corticosteroid therapy can effectively prevent progressive renal failure in patients with IgA-nephropathy who have preserved kidney function (GFR above 70 ml/min).

For patients with impaired renal function, a combination therapy of cyclophosphamide, azathioprine, and corticosteroids has shown effectiveness, but current evidence does not confirm that immunosuppressive therapy is superior to aggressive supportive treatments like ACE inhibitors and lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Present and future therapy options in IgA-nephropathy. Floege, J., Eitner, F.[2021]

In a randomized controlled trial involving 38 patients with progressive IgA nephropathy, the combination of prednisolone (PSL) and losartan (LST) significantly reduced proteinuria more effectively than PSL alone over two years.

Patients receiving PSL plus LST also showed better preservation of renal function, as indicated by less decline in creatinine clearance compared to those treated with PSL alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prednisolone co-administered with losartan confers renoprotection in patients with IgA nephropathy. Horita, Y., Tadokoro, M., Taura, K., et al.[2018]

IgA nephropathy (IgAN) can lead to serious kidney disease, with 25-30% of patients progressing to end-stage renal disease within 20 years, highlighting the need for effective treatments.

Current management strategies for IgAN are limited, with no consensus on immunosuppressive therapy, and patients at high risk for progression should be treated aggressively for hypertension and proteinuria to protect kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of IgA nephropathy. Barratt, J., Feehally, J.[2006]

A European double-blinded, randomized trial is underway to assess the efficacy of ACE-inhibitors (benazepril) in treating young patients with IgA nephropathy, focusing on those under 35 years with moderate proteinuria and fair renal function.

The study aims to clarify the impact of hypertension and various genetic, histological, and immunological factors on the response to ACE-inhibitor treatment over a six-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of IgA nephropathy with angiotensin converting enzyme inhibitors: design of a prospective randomized multicenter trial. Coppo, R., Chiesa, M., Peruzzi, L., et al.[2012]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treating IgA nephropathy: quid novi? [2021]

2. Italy pubmed.ncbi.nlm.nih.gov

Present and future therapy options in IgA-nephropathy. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Prednisolone co-administered with losartan confers renoprotection in patients with IgA nephropathy. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of IgA nephropathy. [2006]

5. Italy pubmed.ncbi.nlm.nih.gov

Treatment of IgA nephropathy with angiotensin converting enzyme inhibitors: design of a prospective randomized multicenter trial. [2012]