Trial · NCT03617536
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
NCT03617536, Phase 2, Completed, Cara Therapeutics, Inc.; results first posted 2024-01-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus. Trials, record NCT03617536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03617536
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
- NCT number
- NCT03617536
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 269 participants, actual
- Lead sponsor
- Cara Therapeutics, Inc.
- Conditions
- Chronic Kidney Diseases, Pruritus
- Interventions
- CR845 0.25 mg Oral Tablet, CR845 0.5 mg Oral Tablet, CR845 1 mg Oral Tablet, Placebo Oral Tablet
- First posted
- 2018-08-06
- Last updated
- 2024-01-24
- Results first posted
- 2024-01-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12 | Baseline, 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. |
| Secondary | Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12 | Baseline, 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. |
| Secondary | Change From Baseline in 5-D Itch Scale Score at the End of Week 12 | Baseline, 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. |
| 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12 | Baseline, Week 12 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12 | Baseline, Week 12 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in 5-D Itch Scale Score at the End of Week 12 | Baseline, Week 12 | score on a scale | LEAST_SQUARES_MEAN | |
| 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 | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12 | CR845 0.25 mg Oral Tablet | -3.99 | 95% Confidence Interval -4.62 to -3.36 | score on a scale | |
| Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12 | CR845 0.5 mg Oral Tablet | -3.84 | 95% Confidence Interval -4.50 to -3.18 | score on a scale | |
| Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12 | CR845 1 mg Oral Tablet | -4.42 | 95% Confidence Interval -5.08 to -3.76 | score on a scale | |
| Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12 | Placebo Oral Tablet | -3.32 | 95% Confidence Interval -3.97 to -2.68 | score on a scale | |
| Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12 | CR845 0.25 mg Oral Tablet | -21.19 | 95% Confidence Interval -24.34 to -18.04 | score on a scale | |
| Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12 | CR845 0.5 mg Oral Tablet | -22.13 | 95% Confidence Interval -25.37 to -18.89 | score on a scale | |
| Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12 | CR845 1 mg Oral Tablet | -23.57 | 95% Confidence Interval -27.00 to -20.14 | score on a scale | |
| Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12 | Placebo Oral Tablet | -19.95 | 95% Confidence Interval -23.17 to -16.73 | score on a scale | |
| Change From Baseline in 5-D Itch Scale Score at the End of Week 12 | CR845 0.25 mg Oral Tablet | -6.17 | 95% Confidence Interval -7.10 to -5.25 | score on a scale | |
| Change From Baseline in 5-D Itch Scale Score at the End of Week 12 | CR845 0.5 mg Oral Tablet | -6.84 | 95% Confidence Interval -7.78 to -5.90 | score on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CR845 0.25 mg Oral Tablet | 69 | |
| Overall Study | STARTED | CR845 0.5 mg Oral Tablet | 66 | |
| Overall Study | STARTED | CR845 1 mg Oral Tablet | 67 | |
| Overall Study | STARTED | Placebo Oral Tablet | 67 | |
| Overall Study | COMPLETED | CR845 0.25 mg Oral Tablet | 60 | |
| Overall Study | COMPLETED | CR845 0.5 mg Oral Tablet | 57 | |
| Overall Study | COMPLETED | CR845 1 mg Oral Tablet | 54 | |
| Overall Study | COMPLETED | Placebo Oral Tablet | 57 | |
| Overall Study | NOT COMPLETED | CR845 0.25 mg Oral Tablet | 9 | |
| Overall Study | NOT COMPLETED | CR845 0.5 mg Oral Tablet | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events200
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperkalaemia | Metabolism and nutrition disorders | CR845 0.25 mg Oral Tablet | 3 | 69 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | CR845 0.5 mg Oral Tablet | 1 | 66 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | CR845 1 mg Oral Tablet | 2 | 67 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Placebo Oral Tablet | 4 | 67 | |
| other | Fatigue | General disorders | CR845 0.25 mg Oral Tablet | 4 | 69 | |
| other | Fatigue | General disorders | CR845 0.5 mg Oral Tablet | 1 | 66 | |
| other | Fatigue | General disorders | CR845 1 mg Oral Tablet | 3 | 67 | |
| other | Fatigue | General disorders | Placebo Oral Tablet | 1 | 67 | |
| other | Hypertension | Vascular disorders | CR845 0.25 mg Oral Tablet | 4 | 69 | |
| other | Hypertension | Vascular disorders | CR845 0.5 mg Oral Tablet | 0 | 66 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CR845 0.25 mg Oral Tablet | 0 | 69 |
| Total, all-cause mortality | CR845 0.5 mg Oral Tablet | 0 | 66 |
| Total, all-cause mortality | CR845 1 mg Oral Tablet | 1 | 67 |
| Total, all-cause mortality | Placebo Oral Tablet | 3 | 67 |
| Total, other adverse events | CR845 0.25 mg Oral Tablet | 12 | 69 |
| Total, other adverse events | CR845 0.5 mg Oral Tablet | 10 | 66 |
| Total, other adverse events | CR845 1 mg Oral Tablet | 15 | 67 |
| Total, other adverse events | Placebo Oral Tablet | 8 | 67 |
| Total, serious adverse events | CR845 0.25 mg Oral Tablet | 9 | 69 |
| Total, serious adverse events | CR845 0.5 mg Oral Tablet | 9 | 66 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03617536
GET https://conductscience.org/api/trials/v1/NCT03617536/events?page=2