Phase 2
N=269
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Chronic Kidney Diseases · Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT03617536 ↗Enrolled (actual)
269
Serious AEs
11.9%
Results posted
Jan 2024
Primary outcome: Primary: Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12 — -3.99; -3.84; -4.42; -3.32 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CR845 0.25 mg Oral Tablet (Drug); CR845 0.5 mg Oral Tablet (Drug); CR845 1 mg Oral Tablet (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cara Therapeutics, Inc.
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12 |
-3.99; -3.84; -4.42; -3.32 | — |
| SECONDARY Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12 |
-21.19; -22.13; -23.57; -19.95 | — |
| SECONDARY Change From Baseline in 5-D Itch Scale Score at the End of Week 12 |
-6.17; -6.84; -6.97; -5.74 | — |
| SECONDARY Reduction of Itch Intensity as Assessed by the Proportion of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12 |
66.2; 64.8; 72.1; 57.9 | — |
Summary
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).
Eligibility Criteria
Inclusion Criteria
To be eligible for inclusion into the study, a patient must meet the following criteria:
- CKD patients with stage III, IV, or V (ie, moderate renal impairment with estimated glomerular filtration rate (GFR) ≥30 and <60 mL/min/1.73 m2 or severe renal impairment with estimated GFR <30 mL/min/1.73 m2).
- For severe CKD patients on hemodialysis, they must be receiving hemodialysis 3 times per week for at least 3 months prior to the start of screening;
- Prior to randomization:
- Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of the 7-day Run-in Period;
- Has a mean baseline Worst Itching Intensity NRS score ≥5, defined as the average of all non-missing scores reported from the start of the 7-day Run-in Period.
Exclusion Criteria
A patient will be excluded from the study if any of the following criteria are met:
- Patients not currently on dialysis who are likely to initiate routine dialysis during study participation;
- Scheduled to receive a kidney transplant during the study;
- New or change of treatment received for itch including antihistamines and corticosteroids (oral, intravenous [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;
- Received ultraviolet B treatment within 30 days prior to the start of screening or anticipates receiving such treatment during the study;
- Participated in a previous clinical study with CR845.
Data sourced from ClinicalTrials.gov (NCT03617536). 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.