Trial Outcomes & Findings for Treatment Response in Dialysis Anaemia (NCT NCT02707757)
NCT ID: NCT02707757
Last Updated: 2021-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
197 participants
Primary outcome timeframe
2 months
Results posted on
2021-04-14
Participant Flow
197 prevalent haemodialysis patients
Recruitment from the study was the prevalent haemodialysis population. Those whom were recruited (197) were then followed until the monthly Hb, taken within routine haemodialysis care, triggered a randomisation event. Exclusion criteria for either recruitment or a randomisation event: Overt blood loss Haematological or other malignancy
Participant milestones
| Measure |
Iron Sucrose
Iron sucrose 200mg for 5 doses
Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
|
Neorecormon
Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
96
|
|
Overall Study
COMPLETED
|
76
|
84
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
Reasons for withdrawal
| Measure |
Iron Sucrose
Iron sucrose 200mg for 5 doses
Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
|
Neorecormon
Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
6
|
4
|
|
Overall Study
Renal transplant/elective operation
|
1
|
5
|
Baseline Characteristics
Treatment Response in Dialysis Anaemia
Baseline characteristics by cohort
| Measure |
Iron Sucrose
n=76 Participants
Iron sucrose 200mg for 5 doses
Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
|
Neorecormon
n=84 Participants
Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Age, Continuous
|
63.22 years
n=93 Participants
|
63.10 years
n=4 Participants
|
63.16 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
34 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
31 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black
|
9 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
76 participants
n=93 Participants
|
84 participants
n=4 Participants
|
160 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Per protocol analysis
Outcome measures
| Measure |
Iron Sucrose
n=76 Participants
Iron sucrose 200mg for 5 doses
Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
|
Neorecormon
n=84 Participants
Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
|
|---|---|---|
|
Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment
|
53 Participants
|
61 Participants
|
Adverse Events
Iron Sucrose
Serious events: 17 serious events
Other events: 2 other events
Deaths: 3 deaths
Neorecormon
Serious events: 21 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Iron Sucrose
n=88 participants at risk
Iron sucrose 200mg for 5 doses
Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
|
Neorecormon
n=96 participants at risk
Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
1.1%
1/88
|
1.0%
1/96
|
|
Cardiac disorders
Cardiac arrhythmia
|
1.1%
1/88
|
2.1%
2/96
|
|
Infections and infestations
Bacteraemia
|
1.1%
1/88
|
2.1%
2/96
|
|
Skin and subcutaneous tissue disorders
Soft tissue infection
|
3.4%
3/88
|
0.00%
0/96
|
|
Musculoskeletal and connective tissue disorders
Cervical discitis
|
1.1%
1/88
|
1.0%
1/96
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
1/88
|
1.0%
1/96
|
|
Immune system disorders
Vasculitis
|
0.00%
0/88
|
1.0%
1/96
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
2.3%
2/88
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/88
|
1.0%
1/96
|
|
Infections and infestations
Catheter related infection
|
1.1%
1/88
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
2/88
|
2.1%
2/96
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.3%
2/88
|
6.2%
6/96
|
|
Infections and infestations
Psoas abscess
|
1.1%
1/88
|
1.0%
1/96
|
|
Nervous system disorders
Stroke
|
0.00%
0/88
|
1.0%
1/96
|
Other adverse events
| Measure |
Iron Sucrose
n=88 participants at risk
Iron sucrose 200mg for 5 doses
Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
|
Neorecormon
n=96 participants at risk
Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
|
|---|---|---|
|
Blood and lymphatic system disorders
Transfusion
|
2.3%
2/88
|
1.0%
1/96
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place