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Trial · NCT03998163

CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

NCT03998163, Phase 3, Completed, Cara Therapeutics, Inc.; results first posted 2021-10-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus. Trials, record NCT03998163. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03998163

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
NCT number
NCT03998163
Status
Completed
Phases
Phase 3
Enrollment
222 participants, actual
Lead sponsor
Cara Therapeutics, Inc.
Conditions
Uremic Pruritus
Interventions
CR845 0.5 mcg/kg
First posted
2019-06-26
Last updated
2021-10-15
Results first posted
2021-10-15

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants With AEs.Up to Follow-Up Visit (Week 13-14)Assessed by monitoring of adverse events.

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With AEs.Up to Follow-Up Visit (Week 13-14)ParticipantsCOUNT_OF_PARTICIPANTS

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants With AEs.CR845 0.5mcg/kg143Participants

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDCR845 0.5mcg/kg222
Overall StudyCOMPLETEDCR845 0.5mcg/kg197
Overall StudyNOT COMPLETEDCR845 0.5mcg/kg25

Adverse events66

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDiarrhoeaGastrointestinal disordersCR845 0.5mcg/kg11222
seriousAnaemiaBlood and lymphatic system disordersCR845 0.5mcg/kg2222
seriousCardio-respiratory arrestCardiac disordersCR845 0.5mcg/kg2222
seriousAcute myocardial infarctionCardiac disordersCR845 0.5mcg/kg1222
seriousAngina pectorisCardiac disordersCR845 0.5mcg/kg1222
seriousAtrial flutterCardiac disordersCR845 0.5mcg/kg1222
seriousChronic left ventricular failureCardiac disordersCR845 0.5mcg/kg1222
seriousPalpitationsCardiac disordersCR845 0.5mcg/kg1222
seriousPrimary adrenal insufficiencyEndocrine disordersCR845 0.5mcg/kg1222
seriousGastrointestinal haemorrhageGastrointestinal disordersCR845 0.5mcg/kg2222

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityCR845 0.5mcg/kg3222
Total, other adverse eventsCR845 0.5mcg/kg11222
Total, serious adverse eventsCR845 0.5mcg/kg45222

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
36039153DERIVEDPubMed
36185706DERIVEDPubMed
37968132DERIVEDPubMed
38196014DERIVEDPubMed
39037824DERIVEDPubMed

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT03998163

GET https://conductscience.org/api/trials/v1/NCT03998163/events?page=2