What side effects are associated with this type of intervention?

Monoclonal antibodies targeting CD38, such as Felzartamab, are being studied for their potential to reduce inflammation and immune response in IgA Nephropathy. Common side effects of these treatments can include infusion-related reactions, such as fever, chills, and nausea. Additionally, immunosuppressive therapies may increase the risk of infections due to the suppression of the immune system. Other potential side effects can include cytopenias (reduced blood cell counts), fatigue, and gastrointestinal disturbances. It is important for patients to discuss these potential risks with their healthcare provider to manage and monitor any adverse effects effectively.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved monoclonal antibodies targeting CD38 for the treatment of IgA Nephropathy. However, various immunosuppressive therapies, including corticosteroids and cyclophosphamide, have been used to manage the condition. Recent studies and trials are exploring the efficacy of monoclonal antibodies like Felzartamab, which aim to reduce inflammation and modulate the immune response in patients with IgA Nephropathy.

What other types of research exist?

Promising alternatives to Felzartamab for IgA Nephropathy patients include: 1) Enteric-budesonide, which has shown potential efficacy in reducing proteinuria with fewer adverse events compared to systemic corticosteroids. 2) Plasma cell-targeting therapies (PCTT) such as bortezomib-based regimens, which have demonstrated complete remission in some refractory cases of IgA vasculitis with underlying monoclonal IgA gammopathy. These alternatives offer potential benefits in managing IgAN by targeting different aspects of the disease pathology.

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Monoclonal Antibodies

Felzartamab for IgA Nephropathy (IGNAZ Trial)

Phase 2

Waitlist Available

Research Sponsored by HI-Bio, A Biogen Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]), but at least of legal age in the given country

Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for ≥ 3 months prior to date of informed consent and adequate blood pressure (BP) control.

Must not have

Diabetes mellitus type 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Felzartamab may include reactions related to the immune system since it targets CD38 proteins which play a role in immunity. Specific side effects aren't listed but could resemble those seen with other monoclonal antibodies such as infusion reactions or increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 1 & 2 trial • 91 Patients • NCT01421186

52%

Plasma cell myeloma

42%

Anaemia

35%

Fatigue

32%

Nausea

26%

Leukopenia

23%

Diarrhea

19%

Infusion related reaction

19%

Nasopharyngitis

19%

Headache

16%

Lymphopenia

16%

Musculoskeletal chest pain

16%

Pyrexia

16%

Hypokalaemia

13%

Constipation

13%

Neutropenia

13%

Plasma Cell Myeloma

13%

Dyspnoea

13%

Infusion-related reaction

13%

Bronchitis

13%

Vomiting

13%

Hypertension

10%

Hypophosphataemia

10%

Hyperhidrosis

10%

Night sweats

10%

Cough

10%

Bone pain

10%

Tachycardia

10%

Thrombocytopenia

10%

Blood lactate dehydrogenase increased

10%

Upper respiratory tract infection

10%

Oedema peripheral

10%

Muscle spasm

10%

Dizziness

10%

Hypotension

10%

Pain in extremity

Dyspnoea exertional

Rhinitis

Nasal congestion

Acute Kidney Injury

Blood creatinine phosphokinase increased

Blood creatinine increased

Respiratory tract infection

Hyperuricaemia

Myalgia

Paraesthesia

Pruritus

Haematoma

Hyperphosphataemia

Rhinorrhoea

Infection

Upper Respiratory Tract Infection

Disease progression

Oral herpes

Visual impairment

Angina pectoris

Polyneuropathy

Confusional state

Vision blurred

Cardiac Failure

Epistaxis

Renal Failure

Renal failure

Spinal Stenosis

Urinary tract infection

Dry mouth

Decreased appetite

Back pain

Erythema

Petechiae

Insomnia

Hyponatraemia

Spinal stenosis

Fall

Pneumonia

Amylase increased

Oropharyngeal pain

Vertigo

Neutrophilia

Leukocytosis

Pain

Dysaesthesia

Abdominal pain

100%

80%

60%

40%

20%

Study treatment Arm

Part A: MOR03087 Biweekly Dose Escalation

Part B: MOR03087 Weekly Dose Escalation

Part C: MOR03087 Plus Dexamethasone

Part D: MOR03087 Plus Pomalidomide + Dexamethasone

Part E: MOR03087 Plus Lenalidomide + Dexamethasone

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Felzartamab Arm #3Experimental Treatment1 Intervention

Group II: Felzartamab Arm #2Experimental Treatment1 Intervention

Group III: Felzartamab Arm #1Experimental Treatment1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Felzartamab

2021

Completed Phase 2

~80

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for IgA Nephropathy aim to reduce inflammation and modulate the immune response. Monoclonal antibodies like felzartamab target CD38 to deplete plasma cells, thereby reducing the production of pathogenic antibodies and inflammation. This is crucial for IgA Nephropathy patients as it helps to control the immune-mediated damage to the kidneys. Additionally, ACE inhibitors and angiotensin receptor blockers (ARBs) are used to manage blood pressure and reduce proteinuria, slowing disease progression. Endothelin receptor antagonists are also being explored for their potential to mitigate kidney damage by blocking pathways involved in inflammation and fibrosis. These treatments collectively help in preserving kidney function and improving patient outcomes.

Emerging strategies for antibody-mediated rejection.Emerging drugs for antibody-mediated rejection after kidney transplantation: a focus on phase II & III trials.Rituximab In The Treatment Of Refractory Idiopathic Membranous Nephropathy In Pakistani Population.