To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus

Conditions

• Chronic Kidney Disease Associated Moderate to Severe Pruritus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nemolizumab — DRUG
  Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 Subcutaneous (SC) injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
• Nemolizumab — DRUG
  Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
• Placebo — DRUG
  Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.

Study Details

The purpose of this study was to evaluate the efficacy of nemolizumab compared to placebo at reducing the intensity of pruritus after a 12-week treatment period in adult hemodialysis participants with moderate to severe pruritus.

Key Dates

Start date

Mar 18, 2022

Status verified

Jan 2025

Primary completion

Jan 4, 2024

Completion

Jan 4, 2024

Study Design

Enrollment

258 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nemolizumab 30 mg
• Experimental: Nemolizumab 60 mg
• Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of Responders With an Improvement of Worst Itch Numeric Rating Scale (WI NRS) Greater Than and Equal to (>=) 4 From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ]

Locations (47)

Related coverage on Hipa.ai

• Nemolizumab Shows Early Pruritus Improvement in CKD-Associated Pruritus
  Nemolizumab · Feb 20, 2025 · ClinicalTrials.gov

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