Phase 3
N=471
CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Uremic Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT03636269 ↗Enrolled (actual)
471
Serious AEs
27.5%
Results posted
Apr 2022
Primary outcome: Primary: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12 — 54.0; 42.2 percentage of subjects — p=0.020
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CR845 0.5 mcg/kg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cara Therapeutics, Inc.
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12 |
54.0; 42.2 | 0.020 sig |
| SECONDARY Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥4 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12 |
41.2; 28.4 | 0.010 sig |
| SECONDARY Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12 |
-16.6; -14.8 | 0.171 |
| SECONDARY Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in 5-D Itch Scale Score at the End of Week 12 |
-4.9; -3.8 | 0.002 sig |
Summary
This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.
Eligibility Criteria
Key Inclusion Criteria
To be eligible for inclusion into the Double-blind Phase of the study, a patient must meet the following criteria:
- Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for at least 3 months prior to the start of screening;
- Has at least 2 single-pool Kt/V measurements ≥1.2, or at least 2 urea reduction ratio measurements ≥65%, or 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% on different dialysis days during the 3 months period prior to screening;
- Prior to randomization:
- Has completed Worst Itching Intensity NRS worksheets up to 8 days prior to 1st dose;
- Has a mean baseline Worst Itching Intensity NRS indicative of moderate to severe uremic pruritus.
- To be eligible for inclusion into the Open-label Extension Phase of the study, each patient will have to fulfill the additional key following criteria at the time of entry into the Open-label Extension Phase:
- Has received at least 30 doses of the planned 36 doses of study drug during the Double-blind Phase of this study;
- Continues to meet inclusion criteria.
Key Exclusion Criteria
A patient will be excluded from the Double-blind Phase of the study if any of the following criteria are met:
- Known noncompliance with dialysis treatment that in the opinion of the investigator would impede completion or validity of the study;
- Scheduled to receive a kidney transplant during the study;
- New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening;
- Received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study;
- Has pruritus only during the dialysis session (by patient report);
- Is receiving ongoing ultraviolet B and anticipates receiving such treatment during the study;
- Participated in a previous clinical study with CR845.
- A patient will be excluded from the Open-label Extension Phase of the study if any of the additional key following criteria are met at the time of entry into the Open-label Extension Phase:
- Completed the Double-blind Phase of this study but exhibited adverse events during the course of the Treatment Period that may preclude continued exposure to the study drug;
- Was noncompliant with protocol procedures during the Double-blind Phase of this study which is indicative of an inability to follow protocol procedures.
Data sourced from ClinicalTrials.gov (NCT03636269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.