Felzartamab for IgA Nephropathy

(IGNAZ Trial)

Recruiting at 60 trial locations

Overseen By Morphosys Clinical Program Lead

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: HI-Bio, A Biogen Company

Must be taking: ACEi, ARB

Disqualifiers: Diabetes, Thrombocytopenia, Neutropenia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

54 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called felzartamab in patients with a kidney disease known as IgA Nephropathy (IgAN). The goal is to see if felzartamab can help by calming down the immune system to protect the kidneys.

Will I have to stop taking my current medications?

The trial requires that you continue taking an ACE inhibitor or angiotensin receptor blocker at the maximum or highest tolerated dose for at least 3 months before joining. The protocol does not specify if you need to stop other medications.

How is the drug Felzartamab unique in treating IgA Nephropathy?

Felzartamab is unique because it targets a specific protein involved in the immune response, potentially offering a more focused approach compared to traditional treatments like steroids or immunosuppressants, which have broader effects on the immune system. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

HI-Bio, A Biogen Company

Eligibility Criteria

Adults aged 18-80 with a biopsy-confirmed diagnosis of IgA Nephropathy (IgAN) within the last 8 years, who have been on maximum or maximally tolerated doses of blood pressure medication for at least 3 months. Women must not be pregnant or breastfeeding and agree to use contraception during and post-trial for three months. Excluded are individuals with certain low blood counts, diabetes type 1, or elevated liver enzymes.

Inclusion Criteria

I am between 18 and 80 years old and of legal age.

You have high levels of protein in your urine during the screening visit.

I've been on the highest dose possible of ACEi or ARB for my blood pressure for over 3 months.

Exclusion Criteria

Your hemoglobin level is less than 90 grams per liter.

Your neutrophil count is less than 1.5 x 10^9/L.

Your liver enzymes are higher than the normal range.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study medication or placebo in a double-blind manner

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Felzartamab
• Placebo

Trial Overview The trial is testing Felzartamab, an anti-CD38 antibody against a placebo in patients with IgAN. It's randomized (participants are assigned by chance), double-blind (neither participants nor researchers know who gets what treatment), multi-center, and aims to see how effective and safe the drug is.

Participant Groups

Group I: Felzartamab Arm #3 Experimental Treatment 1 Intervention

Group II: Felzartamab Arm #2 Experimental Treatment 1 Intervention

Group III: Felzartamab Arm #1 Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

HI-Bio, A Biogen Company

Lead Sponsor

Trials

7

Recruited

300+

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

MorphoSys AG

Lead Sponsor

Trials

27

Recruited

6,600+

HI-Bio

Lead Sponsor

Trials

6

Recruited

180+

Findings from Research

Recent randomized controlled trial results suggest that comprehensive supportive care is more beneficial than immunosuppressive therapy for patients with IgA nephropathy who are at high risk for disease progression.

The findings highlight the ongoing debate regarding the role of immunosuppressive therapy in treating IgA nephropathy, indicating a shift towards supportive care as a preferred approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunosuppression in IgA nephropathy: how certain are we? Floege, J., Rauen, T.[2017]

References

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

Bortezomib for Reduction of Proteinuria in IgA Nephropathy. [2022]

2. England pubmed.ncbi.nlm.nih.gov

IgA mesangial deposits in C3H/HeJ mice after oral immunization with ferritin or bovine serum albumin. [2018]

3. Japan pubmed.ncbi.nlm.nih.gov

Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy: a randomized controlled trial. [2018]

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

Immunosuppression in IgA nephropathy: how certain are we? [2017]

5. England pubmed.ncbi.nlm.nih.gov

IgA mesangial deposits in C3H/HeJ mice after oral immunisation. [2015]