Trial · NCT03422653
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
NCT03422653, Phase 3, Completed, Cara Therapeutics, Inc.; results first posted 2022-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1). Trials, record NCT03422653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03422653
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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 Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
- NCT number
- NCT03422653
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 378 participants, actual
- Lead sponsor
- Cara Therapeutics, Inc.
- Conditions
- Uremic Pruritus
- Interventions
- CR845 0.5 mcg/kg, Placebo
- First posted
- 2018-02-06
- Last updated
- 2022-04-26
- Results first posted
- 2022-04-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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". LS means estimated percent, odds ratio and P value used a logistic regression model. |
| 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 | 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 | 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 | 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 | 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 | 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". LS means estimated percent, odds ratio and P value used a logistic regression model. |
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 | 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 | Week 12 | Data include one patient who had been randomly assigned to the placebo group and who withdrew from the trial before receiving the first dose of placebo. | percentage of subjects | NUMBER |
| 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 | Baseline, Week 12 | Data include one patient who had been randomly assigned to the placebo group and who withdrew from the trial before receiving the first dose of placebo. | score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline, Week 12 | Data include one patient who had been randomly assigned to the placebo group and who withdrew from the trial before receiving the first dose of placebo. | score on a scale | LEAST_SQUARES_MEAN |
| 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 | Week 12 | Data include one patient who had been randomly assigned to the placebo group and who withdrew from the trial before receiving the first dose of placebo. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | CR845 0.5mcg/kg | 51.0 | 95% Confidence Interval 42.9 to 58.9 | percentage of subjects | |
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 | Placebo | 27.6 | 95% Confidence Interval 20.2 to 36.6 | percentage of subjects | |
| 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 | Double-blind CR845 0.5mcg/kg | -5.0 | 95% Confidence Interval -5.7 to -4.4 | score on a scale | |
| 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 | Double-blind Placebo | -3.7 | 95% Confidence Interval -4.4 to -3.1 | score on a scale | |
| 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 | Double-blind CR845 0.5mcg/kg | -17.2 | 95% Confidence Interval -19.6 to -14.7 | score on a scale | |
| 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 | Double-blind Placebo | -12.0 | 95% Confidence Interval -14.5 to -9.6 | score on a scale | |
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 | Double-blind CR845 0.5mcg/kg | 38.9 | 95% Confidence Interval 29.8 to 48.7 | percentage of subjects | |
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 | Double-blind Placebo | 18.0 | 95% Confidence Interval 12.1 to 26.0 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Double-blind Phase | STARTED | Double-blind CR845 0.5mcg/kg | 189 | |
| Period 1: Double-blind Phase | STARTED | Double-blind Placebo | 189 | |
| Period 1: Double-blind Phase | STARTED | Open-label CR845 0.5 mcg/kg | 0 | |
| Period 1: Double-blind Phase | COMPLETED | Double-blind CR845 0.5mcg/kg | 162 | |
| Period 1: Double-blind Phase | COMPLETED | Double-blind Placebo | 170 | |
| Period 1: Double-blind Phase | COMPLETED | Open-label CR845 0.5 mcg/kg | 0 | |
| Period 1: Double-blind Phase | NOT COMPLETED | Double-blind CR845 0.5mcg/kg | 27 | |
| Period 1: Double-blind Phase | NOT COMPLETED | Double-blind Placebo | 19 | |
| Period 1: Double-blind Phase | NOT COMPLETED | Open-label CR845 0.5 mcg/kg | 0 | |
| Period 2: Open-label Phase | STARTED | Double-blind CR845 0.5mcg/kg | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events792
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 | Diarrhoea | Gastrointestinal disorders | Double-blind CR845 0.5mcg/kg | 18 | 189 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-blind Placebo | 10 | 188 | |
| other | Diarrhoea | Gastrointestinal disorders | Open-label CR845 0.5 mcg/kg | 61 | 313 | |
| other | Nasopharyngitis | Infections and infestations | Double-blind CR845 0.5mcg/kg | 6 | 189 | |
| other | Nasopharyngitis | Infections and infestations | Double-blind Placebo | 14 | 188 | |
| other | Nasopharyngitis | Infections and infestations | Open-label CR845 0.5 mcg/kg | 31 | 313 | |
| other | Dizziness | Nervous system disorders | Double-blind CR845 0.5mcg/kg | 13 | 189 | |
| other | Dizziness | Nervous system disorders | Double-blind Placebo | 3 | 188 | |
| other | Dizziness | Nervous system disorders | Open-label CR845 0.5 mcg/kg | 35 | 313 | |
| other | Vomiting | Gastrointestinal disorders | Double-blind CR845 0.5mcg/kg | 10 | 189 |
1 to 10 of 792Source ClinicalTrials.gov
See all 792 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind CR845 0.5mcg/kg | 2 | 189 |
| Total, all-cause mortality | Double-blind Placebo | 2 | 188 |
| Total, all-cause mortality | Open-label CR845 0.5 mcg/kg | 22 | 313 |
| Total, other adverse events | Double-blind CR845 0.5mcg/kg | 40 | 189 |
| Total, other adverse events | Double-blind Placebo | 30 | 188 |
| Total, other adverse events | Open-label CR845 0.5 mcg/kg | 205 | 313 |
| Total, serious adverse events | Double-blind CR845 0.5mcg/kg | 49 | 189 |
| Total, serious adverse events | Double-blind Placebo | 41 | 188 |
| Total, serious adverse events | Open-label CR845 0.5 mcg/kg | 167 | 313 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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/NCT03422653
GET https://conductscience.org/api/trials/v1/NCT03422653/events?page=2