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
Conditions
Interventions
Trade Name: TRENTAL 400
Product Name: Trental400 (Pentoxyphylline)
Product Code: PL 04425/0213
Pharmaceutical Form: Capsule
Pharmaceutic
Sponsors
R&D, Barts and The London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effects Pentoxifylline in ESA resistant ESRD patients on haemodialysis. The primary study endpoints is the ESA requirement relative to the Hb level (is there a difference in a randomised placebo controlled cross-over study)? ; Secondary Objective: Secondary endpoints include: • Safety analysis • Hb values and ESA doses after 6 months of treatment. • Blood sampling will be performed at the start of each hemodialysis session every month. These samples may be subjected to additional analyses to further characterize the pro- and anti-inflammatory effects of pentoxifylline including CRP. • DNA telomere length shortening • Radiological imaging will be performed at Baseline and at 6 months. The effect IMP has on the following radiological parameters will be examined: _ _ _ _ ;Primary end point(s): Endpoints: The primary study endpoints is the ESA requirement relative to the Hb level. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include: • Safety analysis • Hb values and ESA doses after 6 months of treatment. • Blood sampling will be performed at the start of each hemodialysis session every month. These samples may be subjected to additional analyses to further characterize the pro- and anti-inflammatory effects of pentoxifylline including CRP. • DNA telomere length shortening • Radiological imaging will be performed at Baseline and at 6 months. The effect IMP has on the following radiological parameters will be examined: _ _ _ _ ;Timepoint(s) of evaluation of this end point: At the end of the study (cross-over design) | — |
Countries
United Kingdom
Contacts
Public ContactDr Stanley FAN
Barts and The London NHS Trust
Outcome results
None listed