A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Chronic Kidney Diseases Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03617536
• Other study ID #: CR845 210301
• Status: Completed
• Phase: Phase 2
• Start date: July 5, 2018
• Est. completion date: November 14, 2019

Study information

• Verified date: January 2024
• Source: Cara Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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 to 10 days after the last dose of study drug). Informed consent will be obtained prior to performing any study-specific procedures. Screening will occur within 7 to 28 days prior to randomization to assess eligibility.

If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day Run-in Period, they will be randomized in a 1:1:1:1 ratio to receive orally once daily either placebo or CR845 tablets at doses of 0.25, 0.5 or 1 mg. Randomization will be stratified according to the patient's renal disease status: moderate CKD; severe CKD non-dialysis; severe CKD on dialysis (ie, 3 categories). A final safety Follow-up Visit will be conducted 7 to 10 days after the last dose of study drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: November 14, 2019
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of the 7-day Run-in Period;

2. 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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Pruritus
• Renal Insufficiency, Chronic

Intervention

Drug:
• CR845 0.25 mg Oral Tablet
CR845 0.25 mg medication taken orally 1 time/day
• CR845 0.5 mg Oral Tablet
CR845 0.5 mg medication taken orally 1 time/day
• CR845 1 mg Oral Tablet
CR845 1 mg medication taken orally 1 time/day
• Placebo Oral Tablet
Placebo tablet taken orally 1 time/day

Locations

Country	Name	City	State
United States	Cara Therapeutics Study Site	Alexandria	Virginia
United States	Cara Therapeutics Study Site	Augusta	Georgia
United States	Cara Therapeutics Study Site	Bakersfield	California
United States	Cara Therapeutics Study Site 2	Bakersfield	California
United States	Cara Therapeutics Study Site	Baltimore	Maryland
United States	Cara Therapeutics Study Site	Birmingham	Alabama
United States	Cara Therapeutics Study Site	Brooklyn	New York
United States	Cara Therapeutics Study Site	Camp Hill	Pennsylvania
United States	Cara Therapeutics Study Site	Canyon Country	California
United States	Cara Therapeutics Study Site	Columbus	Ohio
United States	Cara Therapeutics Study Site	Corsicana	Texas
United States	Cara Therapeutics Study Site	Crystal Lake	Illinois
United States	Cara Therapeutics Study Site	Denver	Colorado
United States	Cara Therapeutics Study Site	Edgewater	Florida
United States	Cara Therapeutics Study Site	Escondido	California
United States	Cara Therapeutics Study Site	Evanston	Illinois
United States	Cara Therapeutics Study Site	Flint	Michigan
United States	Cara Therapeutics Study Site 2	Flint	Michigan
United States	Cara Therapeutics Study Site	Florence	Alabama
United States	Cara Therapeutics Study Site	Gonzales	Texas
United States	Cara Therapeutics Study Site	Greenville	South Carolina
United States	Cara Therapeutics Study Site	Harrisburg	Arkansas
United States	Cara Therapeutics Study Site	Hialeah	Florida
United States	Cara Therapeutics Study Site	Hollywood	Florida
United States	Cara Therapeutics Study Site	Houston	Texas
United States	Cara Therapeutics Study Site	Houston	Texas
United States	Cara Therapeutics Study Site	Iowa City	Iowa
United States	Cara Therapeutics Study Site	Kansas City	Missouri
United States	Cara Therapeutics Study Site	Lake Worth	Florida
United States	Cara Therapeutics Study Site	Lomita	California
United States	Cara Therapeutics Study Site	Metairie	Louisiana
United States	Cara Therapeutics Study Site 1	Miami	Florida
United States	Cara Therapeutics Study Site 2	Miami	Florida
United States	Cara Therapeutics Study Site	Mineola	New York
United States	Cara Therapeutics Study Site	New Orleans	Louisiana
United States	Cara Therapeutics Study Site	Norman	Oklahoma
United States	Cara Therapeutics Study Site	Northridge	California
United States	Cara Therapeutics Study Site	Ocala	Florida
United States	Cara Therapeutics Study Site	Orlando	Florida
United States	Cara Therapeutics Study Site	Phoenix	Arizona
United States	Cara Therapeutics Study Site	Plano	Texas
United States	Cara Therapeutics Study Site	Prescott	Arizona
United States	Cara Therapeutics Study Site	Providence	Rhode Island
United States	Cara Therapeutics Study Site	Rapid City	South Dakota
United States	Cara Therapeutics Study Site	Riverside	California
United States	Cara Therapeutics Study Site	Rocky Mount	North Carolina
United States	Cara Therapeutics Study Site	Roseville	Michigan
United States	Cara Therapeutics Study Site	Sacramento	California
United States	Cara Therapeutics Study Site	Saint Clair	Michigan
United States	Cara Therapeutics Study Site	San Antonio	Texas
United States	Cara Therapeutics Study Site	San Antonio	Texas
United States	Cara Therapeutics Study Site	Sandy Springs	Georgia
United States	Cara Therapeutics Study Site	Sun City	Arizona
United States	Cara Therapeutics Study Site	Takoma Park	Maryland
United States	Cara Therapeutics Study Site	Tampa	Florida
United States	Cara Therapeutics Study Site	Temple Terrace	Florida
United States	Cara Therapeutics Study Site	Warwick	Rhode Island
United States	Cara Therapeutics Study Site	Washington	District of Columbia
United States	Cara Therapeutics Study Site	Whittier	California
United States	Cara Therapeutics Study Site	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Cara Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12	Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". Higher scores meant worse itch intensity.	Baseline, Week 12
Secondary	Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12	The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. The Skindex-10 has 10 questions; the total Skindex-10 score ranges from 0 to 60. A lower total score represents better quality of life.	Baseline, Week 12
Secondary	Change From Baseline in 5-D Itch Scale Score at the End of Week 12	The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. The 5-D Itch Scale has 5 questions; the total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse responses.	Baseline, Week 12
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		Week 12