Trial Outcomes & Findings for Predictors of Response to Iron and Erythropoietin Stimulating Agents (NCT NCT03658876)
NCT ID: NCT03658876
Last Updated: 2019-07-05
Results Overview
Incrementation of haemoglobin of 5g/l following treatment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
197 participants
Primary outcome timeframe
Within 2 months
Results posted on
2019-07-05
Participant Flow
There were 197 individuals who consented to the study. These were in the observational phase. There were 184 randomisation episodes from these individuals.
Participant milestones
| Measure |
Iron Group
Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
|
EPO Group
Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
96
|
|
Overall Study
COMPLETED
|
76
|
84
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
Reasons for withdrawal
| Measure |
Iron Group
Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
|
EPO Group
Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Intercurrent illness
|
6
|
4
|
|
Overall Study
Transplantation/other operation
|
1
|
5
|
Baseline Characteristics
Predictors of Response to Iron and Erythropoietin Stimulating Agents
Baseline characteristics by cohort
| Measure |
Iron Group
n=76 Participants
Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
|
EPO Group
n=84 Participants
Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Continuous
|
63.22 years
n=5 Participants
|
63.1 years
n=7 Participants
|
63.16 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
76 participants
n=5 Participants
|
84 participants
n=7 Participants
|
160 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 2 monthsIncrementation of haemoglobin of 5g/l following treatment
Outcome measures
| Measure |
EPO Group
n=84 Participants
Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
|
Iron Group
n=76 Participants
Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
|
|---|---|---|
|
Hemoglobin Incrementation
|
61 Participants
|
53 Participants
|
Adverse Events
Iron Group
Serious events: 17 serious events
Other events: 2 other events
Deaths: 3 deaths
EPO Group
Serious events: 21 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Iron Group
n=88 participants at risk
Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
|
EPO Group
n=96 participants at risk
Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
1.1%
1/88 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Cardiac arrhythmia
|
1.1%
1/88 • Number of events 1
|
2.1%
2/96 • Number of events 2
|
|
Infections and infestations
Bacteraemia
|
1.1%
1/88 • Number of events 1
|
2.1%
2/96 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Soft tissue infection
|
3.4%
3/88 • Number of events 3
|
0.00%
0/96
|
|
Musculoskeletal and connective tissue disorders
Cervical discitis
|
1.1%
1/88 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
1/88 • Number of events 2
|
1.0%
1/96 • Number of events 1
|
|
Immune system disorders
Vasculitis
|
0.00%
0/88
|
1.0%
1/96 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
2.3%
2/88 • Number of events 2
|
1.0%
1/96 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/88 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
|
Infections and infestations
Infection related to catheters
|
1.1%
1/88 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
2/88 • Number of events 2
|
2.1%
2/96 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.3%
2/88 • Number of events 2
|
6.2%
6/96 • Number of events 6
|
|
Infections and infestations
Psoas abscess
|
1.1%
1/88 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
|
Nervous system disorders
Stroke
|
0.00%
0/88
|
1.0%
1/96 • Number of events 1
|
Other adverse events
| Measure |
Iron Group
n=88 participants at risk
Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
|
EPO Group
n=96 participants at risk
Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
|
|---|---|---|
|
Blood and lymphatic system disorders
Transfusion
|
2.3%
2/88 • Number of events 2
|
1.0%
1/96 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place