This placebo-controlled, randomized and double-blinded pilot study aims to confirm the previous study performed by Stuard et al. (2010) by proving clinically efficacy and local tolerability of topically applied heparin (Heparin 2,400 IU /ml Cutaneous Spray) in comparison to placebo on suitability of newly constructed primary arteriovenous fistulas in haemodialysed patients AVF at 7 weeks (±1 week) after first study drug administration.
Conditions
Interventions
Product Name: HEPARIN 2,400 IU/ml Cutaneous Spray
Pharmaceutical Form: Suspension and solution for spray
CAS Number: 9041-08-1
Concentration unit: IU international unit(s)
Concentration type: equal
Co
Sponsors
CYATHUS EXQUIRERE PharmaforschungsGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and/or female outpatients • Aged over 18 years • Stage 4 or 5 Chronic kidney Disease according to KDOQI classification • Surgery to create an arteriovenous fistula in the lower arm is planned • If female of childbearing potential: agree to maintain reliable birth control throughout the study and negative (urine) pregnancy test • Subject, who understand the meaning of the study and would be co-operative and sufficiently reliable to use the medication as instructed. • Subject has provided written informed consent prior to undergoing any study procedure. • Patient is on stable daily dose of a thrombocyte aggregation inhibitor (acetyl salicylic acid 50-100 mg, clopidogrel 75 mg or ticlopidin 250 -500mg) 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 56 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known hypersensitivity to any component of the study medication • Subject mentally not capable of adhering to the protocol • History of previous arm (side of planned AVF), neck, or chest surgery/trauma • Anticipated kidney transplant from living donor within the next 3 months • Presence of any comorbidity that limits patient’s life expectancy to less than 6 months. • Subject who is considered incompetent to give an informed consent • Pregnancy / lactation or intention to fall pregnant during the time course of the study • Women of childbearing potential who are not using adequate contraception • Known bleeding disorder or established diagnosis of active or suspected bleeding • Platelet count less than 80 x 109/L • Uncontrolled hypertension: Diastolic blood pressure > 115 mm Hg or Systolic blood pressure > 200 mm Hg • Subject is unable to comply fully with trial requirements according to investigator’s opinion • Participation in any other clinical trial within the previous 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aims of the study are to evaluate the effect of topically applied heparin in comparison to placebo on suitability of newly constructed primary arteriovenous fistulas in patients planned for haemodialysis at 7th week (± 1 week) after first study drug administration.;Secondary Objective: • The suitability of the AVF (dialysis with a blood flow rate = 350mL/min) at 12th and 24th week after first study drug administration • The functional (unassisted) patency of AVF at 7th, 12th and 24th weeks after first study drug administration. • Time to puncture of mature of fistula first time after AVF creation • Flow volume in the AVF by time (ml/min) assessed by ultrasound at 7th week (± 1 week) after first study drug administration. • Time to first intervention (thrombectomy) • Time from AVF creation to abandonment of access (time to failure) • Adequacy of Dialysis: Fistula is considered as adequate for dialysis if it was cannulatedsuccessfully within 6 month post creation with 2 needles over a period of at least 1 month. • Local safety and tolerability profile of IMP by patients and investigator (Global assessment of tolerability). ;Primary end point(s): The suitability of the AVF (dialysis with a blood flow rate = 300 ml/min ) at 7th week (± 1 week) after first study drug administration;Timepoint(s) of evaluation of this end point: week 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The suitability of the AVF (dialysis with a blood flow rate = 300mL/min) at 12th and 24th week after first study drug administration • The functional (unassisted) patency of AVF at 7th, 12th and 24th weeks after first study drug administration. • Time to puncture of mature of fistula first time after AVF creation • Flow volume in the AVF by time (ml/min) assessed by ultrasound at 7th week (± 1 week) after first study drug administration. • Time to first intervention (angioplasty/thrombectomy) • Time from AVF creation to abandonment of access (time to failure) • Adequacy of Dialysis: Fistula is considered as adequate for dialysis if it was cannulated successfully within 6 month post creation with 2 needles over a period of at least 1 month. • Local safety and tolerability profile of IMP by patients and investigator (Global assessment of tolerability).;Timepoint(s) of evaluation of this end point: week 12 and 24 | — |
Countries
Austria
Contacts
Public ContactResearch and Development
Cyathus Exquirere
Outcome results
None listed