Povetacicept for IgA Nephropathy

Recruiting at 373 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

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) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

480 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called povetacicept to determine its effectiveness for people with IgA nephropathy, a kidney condition that causes damage and protein in the urine. The researchers aim to find out if povetacicept can lower protein levels in the urine and help maintain kidney function. Participants will receive either povetacicept or a placebo (a substance with no active medicine) to compare the effects. Individuals diagnosed with IgA nephropathy and high protein levels in their urine might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that povetacicept is likely to be safe for humans?

Research shows that povetacicept is generally safe for people. Earlier studies have shown promising results in treating IgA nephropathy, a kidney disease, with participants reporting good tolerance. These studies found improvements in the disease without major side effects.

This suggests that povetacicept is safe for humans, although individual experiences may differ. Since this treatment is in the final stages of research, it has already undergone several rounds of safety testing, providing a good level of confidence in its safety so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for IgA Nephropathy?

Unlike the standard treatments for IgA Nephropathy, which often include steroids or immunosuppressants, Povetacicept offers a novel approach by targeting the immune system differently. Povetacicept is designed to inhibit both the B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), which are proteins that play a key role in the survival and function of B cells. This dual-targeting mechanism could potentially reduce kidney inflammation and damage more effectively, offering hope for better management of the disease. Researchers are excited about Povetacicept because it may provide a more targeted therapy with fewer side effects compared to traditional treatments.

What evidence suggests that povetacicept might be an effective treatment for IgA nephropathy?

Research has shown that povetacicept, which participants in this trial may receive, may help treat IgA nephropathy. In one study, about 90% of patients no longer had blood in their urine, and 53% experienced a significant improvement in their symptoms. Another study reported a 64% decrease in protein levels in urine and a 69% reduction in a key marker associated with IgA nephropathy. Additionally, patients tolerated povetacicept well, with most experiencing notable improvements. These findings suggest that povetacicept could effectively reduce protein in urine and protect kidney function. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

My daily protein loss in urine is high.

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

My kidney function, measured by eGFR, is at least 30 mL/min.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Povetacicept

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

IgA nephropathy is a common autoimmune kidney disease that can lead to kidney failure, and current treatment options mainly focus on reducing proteinuria through non-specific methods like renin-angiotensin blockade.

There is a significant need for new therapies for IgA nephropathy, as existing treatments, including immunosuppressive agents, are limited and primarily target inflammation rather than the underlying disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating IgA nephropathy: quid novi? Hartono, C., Muthukumar, T.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925006734

Povetacicept for IgA Nephropathy and Primary ... Approximately 90% achieved hematuria resolution and 53% achieved clinical remission. Efficacy outcomes were similar with 240-mg povetacicept.

2. journals.lww.com journals.lww.com/jasn/fulltext/2024/10001/results_from_longer_follow_up_with_povetacicept,.2377.aspx

Results from Longer Follow-Up with Povetacicept, an... At 9 mo (n=6), a 64% reduction in UPCR and 69% reduction in Gd-IgA1 were achieved with povetacicept 80 mg; 67% of pts achieved remission, all pts with hematuria ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06564142

NCT06564142 | Evaluation of Efficacy of Povetacicept in ... The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal ...

4. asn-online.org asn-online.org/education/kidneyweek/2024/program-abstract.aspx?controlId=4124020

Kidney Week Povetacicept was well tolerated at both dose levels. At 9 mo (n=6), a 64% reduction in UPCR and 69% reduction in Gd-IgA1 were achieved with povetacicept 80 mg; ...

5. biospace.com biospace.com/alpine-immune-sciences-shares-updated-clinical-data-from-povetacicept-in-iga-nephropathy

Alpine Immune Sciences Shares Updated Clinical Data ... Povetacicept administered subcutaneously once every four weeks continues to be well tolerated in IgA nephropathy, with UPCR reductions of greater than 60% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11532938/

A first‐in‐human, randomized study of the safety ... Based upon these preclinical data, povetacicept has the potential to improve outcomes in patients suffering from severe antibody‐associated ...