E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
Efficacy and local tolerability of topically applied heparin newly constructed primary arteriovenous fistulas in haemodialysed patients AVF at 7 weeks (±1 week) after first study drug administration. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
• 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).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |