PRIME: Treatment Response in Dialysis Anaemia

• Sponsor: Imperial College Healthcare NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT02707757
• Collaborator: (none)
• Enrollment: 197
• Locations: 2
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 98.5
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. The current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. This study is designed to investigate the factors which predict which agent would produce a better response. Patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of ESA as they are currently, but allocated at random rather than by poorly performing biochemical markers. The iron treated and ESA treated groups can then be analysed for factors which predict response in o

Condition or Disease	Intervention/Treatment	Phase
Anaemia; Haemodialysis	Drug: Iron sucrose; Drug: Erythopoietin stimulating agent	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 197 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Iron sucrose Iron sucrose 200mg for 5 doses	Drug: Iron sucrose; 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl; Other Names: Venofer
Active Comparator: Neorecormon Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000	Drug: Erythopoietin stimulating agent; Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria; Other Names: Neorecormon

Outcome Measures

Primary Outcome Measures

1. Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will be eligible for inclusion if they have been on dialysis for more than 3 months

Exclusion Criteria:

• Patients with a bone marrow disorder, active infection or active malignancy will be excluded as these are non-renal causes of anaemia. Patients unable to give informed consent will also not be included within the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imperial Renal and Transplant Centre	London		United Kingdom	W12 0HS
2	Imperial NHS Healthcare Trust	London		United Kingdom

Sponsors and Collaborators

• Imperial College Healthcare NHS Trust

Investigators

• Principal Investigator: Damien Dr Ashby, MBBS, Imperial College Healthcare NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College Healthcare NHS Trust
• ClinicalTrials.gov Identifier: NCT02707757
• Other Study ID Numbers: 14HH1987
• First Posted: Mar 14, 2016
• Last Update Posted: Apr 14, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Imperial College Healthcare NHS Trust: Haemodialysis; Anaemia; Iron; Erythropoeitin stimulating agents
• Additional relevant MeSH terms: Anemia; Ferric Oxide, Saccharated

Study Results

Participant Flow

Recruitment Details	197 prevalent haemodialysis patients
Pre-assignment Detail	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

Arm/Group Title	Iron Sucrose	Neorecormon
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	88	96
COMPLETED	76	84
NOT COMPLETED	12	12

Baseline Characteristics

Arm/Group Title	Iron Sucrose	Neorecormon	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	76	84	160
Age (Count of Participants)
<=18 years	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 51.3%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	63.22	63.10	63.16
Sex: Female, Male (Count of Participants)
Female	22 28.9%	24 28.6%	46 28.8%
Male	54 71.1%	60 71.4%	114 71.3%
Race/Ethnicity, Customized (Count of Participants)
White	34 44.7%	41 48.8%	75 46.9%
Asian	31 40.8%	28 33.3%	59 36.9%
Black	9 11.8%	12 14.3%	21 13.1%
Other	2 2.6%	3 3.6%	5 3.1%
Region of Enrollment (participants) [Number]
United Kingdom	76 100%	84 100%	160 100%

Outcome Measures

1. Primary Outcome

Title	Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

Per protocol analysis

Arm/Group Title	Iron Sucrose	Neorecormon
Arm/Group Description	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	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
Measure Participants	76	84
Count of Participants [Participants]	53 69.7%	61 72.6%

Adverse Events

Arm/Group Title	Iron Sucrose		Neorecormon
Arm/Group Description	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		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
All Cause Mortality
	Iron Sucrose		Neorecormon
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/88 (3.4%)		2/96 (2.1%)
Serious Adverse Events
	Iron Sucrose		Neorecormon
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/88 (19.3%)		21/96 (21.9%)
Cardiac disorders
Acute coronary syndrome	1/88 (1.1%)		1/96 (1%)
Cardiac arrhythmia	1/88 (1.1%)		2/96 (2.1%)
Gastrointestinal disorders
Dyspepsia	1/88 (1.1%)		1/96 (1%)
Immune system disorders
Vasculitis	0/88 (0%)		1/96 (1%)
Infections and infestations
Bacteraemia	1/88 (1.1%)		2/96 (2.1%)
Catheter related infection	1/88 (1.1%)		1/96 (1%)
Psoas abscess	1/88 (1.1%)		1/96 (1%)
Musculoskeletal and connective tissue disorders
Cervical discitis	1/88 (1.1%)		1/96 (1%)
Hip fracture	2/88 (2.3%)		1/96 (1%)
Nervous system disorders
Stroke	0/88 (0%)		1/96 (1%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/88 (1.1%)		1/96 (1%)
Pleural effusion	2/88 (2.3%)		2/96 (2.1%)
Pneumonia	2/88 (2.3%)		6/96 (6.3%)
Skin and subcutaneous tissue disorders
Soft tissue infection	3/88 (3.4%)		0/96 (0%)
Other (Not Including Serious) Adverse Events
	Iron Sucrose		Neorecormon
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/88 (2.3%)		1/96 (1%)
Blood and lymphatic system disorders
Transfusion	2/88 (2.3%)		1/96 (1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.