Efficacy and Local Tolerability of Topically Applied Heparin on the Suitability of Newly Constructed Primary Arteriovenous Fistulas in Patients Planned for Haemodialysis

NCT01382888 | Terminated Phase 2 DMC

• 2 other identifiers: CYT/Heparin - 01/112011-000455-16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this study is 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.

Conditions

Haemodialysis

Keywords

Haemodialysis; Arteriovenous fistula; Severe chronic kidney disease; Newly constructed primary arteriovenous fistulas in patients planned for haemodialysis

Outcome Measures

Primary Outcomes (1)

• Dialysis with a blood flow rate ≥ 300 ml/min OR, if the patient is not in need of dialysis, by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression

  Primary outcome measure is the suitability of the AVF (dialysis with a blood flow rate ≥ 300 ml/min ) at 7th week (± 1 week) after first study drug administration. Suitability of the AVF will be assessed by using the AVF for dialysis. If a flow rate of at least 300 ml/min can be reached for at least 3 minutes suitability is fulfilled.If the patient is not in need of dialysis, suitability will be assessed by combining the venous diameter \> 0.4 cm and flow volume \> 500ml/min assessed by duplex ultrasound, as well as via clinical impression

  7 ± 1 week

Secondary Outcomes (3)

• Dialysis with a blood flow rate ≥ 300mL/min. If the patient is not in need of dialysis, by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression.

  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

• Local safety and tolerability profile of IMP by patients and investigator (Global assessment of tolerability)

  24 weeks

Study Arms (2)

Heparin 2,400 IU /ml Cutaneous Spray

ACTIVE COMPARATOR

Patients are randomized to receive the active comparator heparin 2,400 IU/ml cutaneous spray for 24 weeks

Drug: Heparin 2,400 IU /ml Cutaneous Spray

Placebo Cutaneous Spray

PLACEBO COMPARATOR

Patients are randomized to receive placebo cutaneous spray for 24 weeks

Drug: Placebo Cutaneous Spray

Interventions

Heparin 2,400 IU /ml Cutaneous Spray DRUG

Randomization will be performed 2 - 14 days post fistula creation surgery following confirmation that the fistula is patent by physical examination. Patients that are randomized to this study arm, will be asked to administer the study medication twice daily. Patients will get adequate training before first administration.

Heparin 2,400 IU /ml Cutaneous Spray

Placebo Cutaneous Spray DRUG

Randomization will be performed 2 - 14 days post fistula creation surgery following confirmation that the fistula is patent by physical examination. Patients that are randomized to this study arm, will be asked to administer the study medication (placebo) twice daily. Patients will get adequate training before first administration.

Placebo Cutaneous Spray

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Known hypersensitivity to any component of the study medication
• 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.
• Pregnancy / lactation or intention to fall pregnant during the time course of the study and 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 10\^9/L
• Uncontrolled hypertension: Diastolic blood pressure \> 115 mm Hg or Systolic blood pressure \> 200 mm Hg

Sponsors & Collaborators

• Cyathus Exquirere Pharmaforschungsgmbh: lead

Study Sites (3)

Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse, Medizinische Universität Wien

Vienna, Vienna, 1090, Austria

Location

6. Medizinische Abteilung mit Nephrologie und Dialyse, Wilhelminenspital Wien

Vienna, Vienna, 1160, Austria

Location

Krankenhaus der Elisabethinen Linz

Linz, 4020, Austria

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Renal Insufficiency, Chronic

Interventions

Heparin

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; 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

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 27, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

AU (3)