Trial Outcomes & Findings for CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (NCT NCT03998163)
NCT ID: NCT03998163
Last Updated: 2021-10-15
Results Overview
Assessed by monitoring of adverse events.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
222 participants
Primary outcome timeframe
Up to Follow-Up Visit (Week 13-14)
Results posted on
2021-10-15
Participant Flow
Participant milestones
| Measure |
CR845 0.5mcg/kg
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week
|
|---|---|
|
Overall Study
STARTED
|
222
|
|
Overall Study
COMPLETED
|
197
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Baseline characteristics by cohort
| Measure |
CR845 0.5mcg/kg
n=222 Participants
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week
|
|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
110 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Follow-Up Visit (Week 13-14)Assessed by monitoring of adverse events.
Outcome measures
| Measure |
CR845 0.5mcg/kg
n=222 Participants
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week
|
|---|---|
|
Number of Participants With AEs.
|
143 Participants
|
Adverse Events
CR845 0.5mcg/kg
Serious events: 45 serious events
Other events: 11 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
CR845 0.5mcg/kg
n=222 participants at risk
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.90%
2/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.90%
2/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Cardiac disorders
Angina pectoris
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Cardiac disorders
Atrial flutter
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Cardiac disorders
Palpitations
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Endocrine disorders
Primary adrenal insufficiency
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.90%
2/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Gastrointestinal disorders
Enterocoloitis
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Gastrointestinal disorders
Faecaloma
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Gastrointestinal disorders
Haematemesis
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorhage
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Gastrointestinal disorders
Vomiting
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
General disorders
Asthenia
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
General disorders
Death
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
General disorders
Non-cardiac chest pain
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Clostridium difficile colitis
|
1.4%
3/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Sepsis
|
1.4%
3/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Influenza
|
0.90%
2/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Osteomyelitis
|
0.90%
2/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Pneumonia
|
0.90%
2/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Bronchitis
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Cystitis
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Endocarditis
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Localised infection
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Orchitis
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Pneumococcal sepsis
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Pneumonia viral
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Pseudomonas infection
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Rhinovirus infection
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Septic shock
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.4%
3/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Injury, poisoning and procedural complications
Fall
|
0.90%
2/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Investigations
Corynebacterium test positive
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
5/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.90%
2/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Musculoskeletal and connective tissue disorders
Diffuse idiopathic skeletal hyperostosis
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Musculoskeletal and connective tissue disorders
Thoracic spinal stenosis
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Nervous system disorders
Syncope
|
1.4%
3/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Nervous system disorders
Presyncope
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Nervous system disorders
Radiculopathy
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Psychiatric disorders
Mental status changes
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.90%
2/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Vascular disorders
Hypertensive urgency
|
0.90%
2/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Vascular disorders
Hypertensive crisis
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Vascular disorders
Hypertensive emergency
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
|
Vascular disorders
Hypotension
|
0.45%
1/222 • Up to Follow-Up Visit (Week 13-14)
|
Other adverse events
| Measure |
CR845 0.5mcg/kg
n=222 participants at risk
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
11/222 • Up to Follow-Up Visit (Week 13-14)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place