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Predictors of Response to Iron and Erythropoietin Stimulating Agents (PRIME)

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ClinicalTrials.gov Identifier: NCT03658876
Recruitment Status : Completed
First Posted : September 5, 2018
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Renal Failure Chronic
Anemia
Interventions Drug: Iron Sucrose Solution for Injection
Drug: Epoetin Beta
Enrollment 197
Recruitment Details  
Pre-assignment Details There were 197 individuals who consented to the study. These were in the observational phase. There were 184 randomisation episodes from these individuals.
Arm/Group Title Iron Group EPO Group
Hide Arm/Group Description Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
Period Title: Overall Study
Started 88 96
Completed 76 84
Not Completed 12 12
Reason Not Completed
Protocol Violation             3             2
Withdrawal by Subject             2             0
Death             0             1
Intercurrent illness             6             4
Transplantation/other operation             1             5
Arm/Group Title Iron Group EPO Group Total
Hide Arm/Group Description Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000 Total of all reporting groups
Overall Number of Baseline Participants 76 84 160
Hide Baseline Analysis Population Description
This study was analysed on a per protocol rather than intention to treat basis
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 84 participants 160 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
37
  48.7%
41
  48.8%
78
  48.8%
>=65 years
39
  51.3%
43
  51.2%
82
  51.2%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 76 participants 84 participants 160 participants
63.22
(31 to 86)
63.1
(25 to 91)
63.16
(25 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 84 participants 160 participants
Female
22
  28.9%
24
  28.6%
46
  28.7%
Male
54
  71.1%
60
  71.4%
114
  71.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 84 participants 160 participants
White
34
  44.7%
41
  48.8%
75
  46.9%
Black
9
  11.8%
12
  14.3%
21
  13.1%
Asian
31
  40.8%
28
  33.3%
59
  36.9%
Other
2
   2.6%
3
   3.6%
5
   3.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 76 participants 84 participants 160 participants
76 84 160
1.Primary Outcome
Title Hemoglobin Incrementation
Hide Description Incrementation of haemoglobin of 5g/l following treatment
Time Frame Within 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EPO Group Iron Group
Hide Arm/Group Description:
Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
Overall Number of Participants Analyzed 84 76
Measure Type: Count of Participants
Unit of Measure: Participants
61
  72.6%
53
  69.7%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iron Group EPO Group
Hide Arm/Group Description Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
All-Cause Mortality
Iron Group EPO Group
Affected / at Risk (%) Affected / at Risk (%)
Total   3/88 (3.41%)      2/96 (2.08%)    
Show Serious Adverse Events Hide Serious Adverse Events
Iron Group EPO Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/88 (19.32%)      21/96 (21.88%)    
Cardiac disorders     
Acute coronary syndrome  1  1/88 (1.14%)  1 1/96 (1.04%)  1
Cardiac arrhythmia  1 [1]  1/88 (1.14%)  1 2/96 (2.08%)  2
Gastrointestinal disorders     
Dyspepsia  1 [2]  1/88 (1.14%)  2 1/96 (1.04%)  1
Immune system disorders     
Vasculitis  1  0/88 (0.00%)  0 1/96 (1.04%)  1
Infections and infestations     
Bacteraemia  1  1/88 (1.14%)  1 2/96 (2.08%)  2
Infection related to catheters  1 [3]  1/88 (1.14%)  1 1/96 (1.04%)  1
Psoas abscess  1  1/88 (1.14%)  1 1/96 (1.04%)  1
Musculoskeletal and connective tissue disorders     
Cervical discitis  1  1/88 (1.14%)  1 1/96 (1.04%)  1
Hip fracture  1 [4]  2/88 (2.27%)  2 1/96 (1.04%)  1
Nervous system disorders     
Stroke  1  0/88 (0.00%)  0 1/96 (1.04%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/88 (1.14%)  1 1/96 (1.04%)  1
Pleural effusion  1  2/88 (2.27%)  2 2/96 (2.08%)  2
Pneumonia  1  2/88 (2.27%)  2 6/96 (6.25%)  6
Skin and subcutaneous tissue disorders     
Soft tissue infection  1 [5]  3/88 (3.41%)  3 0/96 (0.00%)  0
1
Term from vocabulary, MedRA
Indicates events were collected by systematic assessment
[1]
1 episode of arrhythmia on dialysiand and one episode of atrial fibrillation with fast ventricular rate
[2]
Hospital admission due to clinical concern of cardiac event
[3]
Infections related to tunnelled haemodialysis access
[4]
Following falls
[5]
1 diabetic foot and 1 cellulitis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Iron Group EPO Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/88 (2.27%)      1/96 (1.04%)    
Blood and lymphatic system disorders     
Transfusion  1  2/88 (2.27%)  2 1/96 (1.04%)  1
1
Term from vocabulary, MedRA
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Damien Ashby
Organization: Imperial Healthcare NHS Trust
EMail: d.ashby@imperial.ac.uk
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03658876     History of Changes
Other Study ID Numbers: 14HH1987
First Submitted: August 30, 2018
First Posted: September 5, 2018
Results First Submitted: February 26, 2019
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019