What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) include medications to manage symptoms and complications such as high blood pressure, anemia, and pruritus. For pruritus, treatments like antihistamines, corticosteroids, and newer agents like Nemolizumab (an anti-IL-31 receptor A monoclonal antibody) are used. Known side effects of these treatments can include drowsiness and dry mouth (antihistamines), weight gain and increased blood sugar (corticosteroids), and injection site reactions or mild immunologic effects (monoclonal antibodies like Nemolizumab).

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Kidney Disease (CKD), particularly focusing on managing complications such as anemia, mineral and bone disorders, and cardiovascular issues. However, specific treatments targeting pruritus in CKD, similar to Nemolizumab (an Anti-IL-31 Receptor A Monoclonal Antibody), are less common. Nemolizumab is currently being studied for its efficacy in reducing pruritus in CKD patients, a symptom that significantly affects quality of life. Other treatments for pruritus in CKD have included antihistamines, gabapentin, and topical therapies, but none specifically target the IL-31 pathway as Nemolizumab does.

What other types of research exist?

Promising novel alternatives to Nemolizumab for CKD patients in 2024 include: 1) Daratumumab, which has shown efficacy in treating AL amyloidosis with renal involvement, potentially addressing pruritus indirectly by improving kidney function. 2) Ixazomib, an oral proteasome inhibitor, which has demonstrated positive outcomes in relapsed or refractory AL amyloidosis and may offer benefits for CKD-related complications. 3) Lenvatinib plus Pembrolizumab, which has been effective in treating advanced renal cell carcinoma and may provide benefits for CKD patients with associated malignancies.

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Monoclonal Antibodies

Nemolizumab for Itching in Chronic Kidney Disease (NemoCKDaP Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Galderma R&D

Eligibility Criteria Checklist

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

Must have

Pruritus for >= three months (documented pruritus with no etiology identified other than CKD by medical record, previous physician's letter/statement, or a written conversation of site investigators).

WI NRS score >= 5.0 at the screening and baseline visit. Screening WI NRS score will be determined by a single WI NRS assessment (score ranging from 0 to 10) for the 24-hour period immediately preceding the screening visit. Baseline WI NRS score will be determined based on the weekly average of daily WI NRS scores (score ranging from 0 to 10) during the seven days immediately preceding baseline (rounding is not permitted). A minimum of four daily scores out of the seven days immediately preceding baseline is required for this calculation.

Must not have

Body weight less than (<) 30 kg.

Pruritus present only during hemodialysis session.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 12

Awards & highlights

Summary

This trial will test if nemolizumab is better than placebo at reducing itchiness in adults with kidney disease who are on dialysis.

Who is the study for?

Adults on hemodialysis for chronic kidney disease with moderate to severe itching (pruritus) lasting over three months can join. They must have a stable dialysis routine, no recent infections or hospitalizations for asthma, and not be pregnant or breastfeeding. Women able to have children must agree to use contraception or practice abstinence.Check my eligibility

What is being tested?

The trial is testing Nemolizumab against a placebo in reducing itchiness over 12 weeks in adults undergoing hemodialysis. Participants will randomly receive either the study drug or a placebo without knowing which one they are getting.See study design

What are the potential side effects?

Potential side effects of Nemolizumab may include reactions at the injection site, increased risk of infections due to immune system changes, and possible allergic responses among those sensitive to immunoglobulin products.

Eligibility Criteria

Inclusion Criteria

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

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I have had itching for 3 months or more, with no cause found other than kidney disease.

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My pain level has been 5 or more out of 10 for the past week.

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I agree to not become pregnant or use birth control during and for 12 weeks after the study.

Exclusion Criteria

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

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My body weight is under 30 kg.

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I only experience itching during my dialysis sessions.

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I have severe heart symptoms or had a heart attack in the last 3 months.

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I was hospitalized for asthma in the last year.

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My asthma symptoms have been frequent and disruptive in the last 3 months.

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My asthma control score is 19 or less.

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I haven't had a skin infection or needed strong infection medicine in the last 2 weeks.

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I do not have active or untreated TB.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I am scheduled for a major surgery or kidney transplant during the study.

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I have been treated with nemolizumab before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Responders with an Improvement of Worst Itch Numeric Rating Scale (WI NRS) greater than and equal to (>=) 4 of from Baseline at Week 12

Secondary outcome measures

Proportion of Participants with an Improvement of >=3 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 12

Proportion of Participants with an Improvement of >=3 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 4

Proportion of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 12

+2 more

Other outcome measures

Percentage of Participants with an Improvement of >=3 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 4

Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 12

Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 4

+1 more

Side effects data

From 2018 Phase 2 trial • 226 Patients • NCT03100344

33%

Nasopharyngitis

20%

Dermatitis atopic

13%

Headache

Nausea

Sinusitis

Upper respiratory tract infection

Urinary tract infection

Diarrhoea

Oral herpes

Asthma

Blood creatine phosphokinase increased

Back pain

Arthralgia

Pyrexia

Cough

Cardio-respiratory arrest

Abdominal pain

Staphylococcal sepsis

Asthenia

Post-traumatic amnestic disorder

Pneumonia aspiration

100%

80%

60%

40%

20%

Study treatment Arm

Nemolizumab (10 mg)

Nemolizumab (90 mg)

Nemolizumab (30 mg)

Placebo

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Nemolizumab 60 mgExperimental Treatment1 Intervention

Group II: Nemolizumab 30 mgExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nemolizumab

2021

Completed Phase 3

~2750

0 / 14Eligibility 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

Chronic Kidney Disease (CKD) treatments often target inflammation and immune responses, which are critical in disease progression. Nemolizumab, an Anti-IL-31 Receptor A Monoclonal Antibody, works by inhibiting the IL-31 pathway, reducing inflammation and pruritus, a common and distressing symptom in CKD patients. Other common treatments include Renin-Angiotensin-Aldosterone System (RAAS) inhibitors, which lower blood pressure and reduce proteinuria, thereby slowing kidney damage. Immunosuppressive therapies, such as corticosteroids and cyclophosphamide, are used to manage autoimmune components of CKD. These treatments are essential as they help manage symptoms, slow disease progression, and improve the quality of life for CKD patients.

Therapies Targeting Epigenetic Alterations in Acute Kidney Injury-to-Chronic Kidney Disease Transition.Molecular targeting of renal inflammation using drug delivery technology to inhibit NF-κB improves renal recovery in chronic kidney disease.Effect of renin-angiotensin-aldosterone system inhibition, dietary sodium restriction, and/or diuretics on urinary kidney injury molecule 1 excretion in nondiabetic proteinuric kidney disease: a post hoc analysis of a randomized controlled trial.