Pentoxifylline in EPOr

Phase 1

• Conditions: We shall study patients with renal failure on dialysis. We shall particularly focus on patients with evidence of erythopoeitin stimulating agent (ESA) resistance.; MedDRA version: 14.1 Level: LLT Classification code 10014647 Term: End stage renal failure System Organ Class: 100000004857; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-006168-30-GB
• Lead Sponsor: R&D, Barts and The London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-15
• Study Completion: 2017-09-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

•Be able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff;
•Willing to comply with study restrictions;
•Between 18 and 65 years of age (inclusive).
•Diagnosis of clinically stable ESRD, as determined by the investigator;
•Requiring regular dialysis therapy for at least 12 weeks prior to first administration of study agent;
•Receiving treatment with IV or SC erythropoietin receptor agonist at least weekly (ie exclude Micera or other ESAs given fortnightly or monthly) for a minimum of 8 weeks prior to administration of study agent, requiring doses to remedy EPO-resistance (requiring >12,000iu equivalent of EPO per week), with evidence of stable hemoglobin levels;
•Baseline hemoglobin values between 9.0 and 12.0 g/dL before entering the study;
•CRP levels of =5 mg/L

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•Clinically relevant abnormal history of physical and mental health other than conditions related to chronic kidney disease of patient, as determined by medical history taking (as judged by the investigator);
•Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to chronic kidney disease of patient (as judged by the investigator);
•Subject has uncontrolled hypertension;
•Subject is unable to refrain from the use of disallowed concomitant medication from one week prior to the first study drug administration until follow-up assessments (see section 3.3);
•Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug that might interfere with the primary or secondary endpoints;
•Subject has undergone major surgery within six months prior to screening;
•Any other condition that in the opinion of the investigator would complicate or compromise the study (e.g. known haemoglobinopathy), or the well being of the subject.
•Females of child-bearing potential who are not willing to use contraception for the duration of the study.
•Subject is known hypersensitivity to the active constituent, pentoxifylline other methyl xanthines or any of the excipients.
•Subjects with recent cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction and severe cardiac arrhythmias

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified