Predictors of Response to Iron and Erythropoietin Stimulating Agents

NCT03658876 | Completed Phase 4 Results DMC

• 1 other identifier: 14HH1987
• Study Type: interventional
• Target: 197
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to identify predictors of treatment response. This involves collected baseline clinical parameters and bloods for biochemical parameters prior to administering the study treatment. A positive outcome following treatment was defined as an uptitration of haemoglobin by greater than 5g/l within 2 months. The study evaluated the participants response to treatment against the clinical and biochemical information collected prior to treatment being received.

Conditions

Renal Failure Chronic; Anemia

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Hemoglobin Incrementation

  Incrementation of haemoglobin of 5g/l following treatment

  Within 2 months

Study Arms (2)

EPO group

ACTIVE COMPARATOR

Drug: Epoetin Beta

Iron group

ACTIVE COMPARATOR

Drug: Iron Sucrose Solution for Injection

Interventions

Iron Sucrose Solution for Injection DRUG

200mg iron sucrose given on 5 successive haemodialysis sessions

Iron group

Epoetin Beta DRUG

Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000

Also known as: Neorecormon

EPO group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All prevalent haemodialysis patients, established for greater than 3 months

You may not qualify if:

• Inability to consent Bone marrow disorder Transfusion dependence Active bleeding Active infection Active malignancy Frail with either frequent hospital admissions or unable to follow trial protocol due to differing target haemoglobin

Sponsors & Collaborators

• Imperial College London: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Injections; epoetin beta

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr Damien Ashby
• Organization: Imperial Healthcare NHS Trust

d.ashby@imperial.ac.uk

Study Officials

• Damien Ashby, MBBS

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 5, 2018
• Study Start: June 3, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2017
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share