Sirolimus for Arteriovenous Fistula

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
The Regional Medical Center/Dialysis Access Institute, Orangeburg, SC
Arteriovenous Fistula+10 More
Sirolimus - Drug
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.

Eligible Conditions

  • Renal Failure, Chronic Renal Failure
  • ESRD
  • Complication of Hemodialysis
  • Vascular Access Complications
  • End Stage Renal Disease (ESRD)
  • Complication of Renal Dialysis
  • Arteriovenous Fistula

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Arteriovenous Fistula

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 6 Months

6 Months
Clinical Fistula Maturation (FM)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Arteriovenous Fistula

Side Effects for

CellCept + CNI (Tacrolimus or Cyclosporine)
29%Diarrhoea
18%Abdominal Pain
16%Hepatitis C
16%Nausea
16%Fatigue
16%Headache
14%Vomiting
14%Pyrexia
14%Leukopenia
12%Oedema Peripheral
11%Insomnia
10%Back Pain
10%Hyperkalaemia
10%Tremor
10%Anaemia
10%Hypertension
9%Arthralgia
9%Pruritis
9%Cough
8%Pain in Extremity
8%Abdominal Pain Upper
8%Hepatic Enzyme Increased
8%Dizziness
8%Neutropenia
7%Constipation
7%Sinusitis
7%Weight Decreased
7%Dyspnoea
6%White Blood Cell Count Decreased
6%Blood Creatinine Increased
6%Liver Function Test Abnormal
5%Nasopharyngitis
5%Depression
5%Jaundice
5%Asthenia
5%Upper Respiratory Tract Infection
5%Decreased Appetite
5%Weight Increased
5%Muscle Spasms
5%Incision Site Pain
5%Renal Failure
4%Night Sweats
4%Oropharyngeal Pain
4%Anorexia
4%Rhinorrhoea
3%Hyperlipidaemia
3%Thrombocytopenia
3%Rash
3%Incisional Hernia
3%Pleural Effusion
3%Acne
3%Myalgia
2%Sepsis
2%Pneumonia
2%Hypokalaemia
1%Bile Duct Stenosis
1%Biliary Tract Disorder
1%Acarodermatitis
1%Lobar Pneumonia
1%Inguinal Hernia
1%Bile Duct Obstruction
1%Hepatic Failure
1%Ventricular Tachycardia
1%Procedural Pain
1%Hyperglycaemia
1%Blood Glucose Increased
1%Clostridium Difficile Colitis
1%Viral Infection
1%Bacteraemia
1%Escherichia Urinary Tract Infection
1%Cellulitis
1%Clostridial Infection
1%Diverticulitis
1%Influenza
1%Lactobacillus Infection
1%Pseudomonal Sepsis
1%Staphylococcal Infection
1%Gastrointestinal Haemorrhage
1%Umbilical Hernia
1%Crohn's Disease
1%Abdominal Hernia
1%Peritonitis
1%Gastritis
1%Biliary Anastomosis Complication
1%Complications of Transplanted Kidney
1%Post Procedural Haemorrhage
1%Cholestasis
1%Hepatic Artery Stenosis
1%Autoimmune Hepatitis
1%Portal Vein Thrombosis
1%Hepatic Function Abnormal
1%Chest Pain
1%Multi-Organ Failure
1%Epstein-Barr Virus Associated Lymphoproliferative Disorder
1%Desmoid Tumour
1%Gastrointestinal Tract Adenoma
1%Adenocarcinoma
1%Malaise
1%Hepatic Cancer Metastatic
1%B-Cell Lymphoma
1%Hepatic Neoplasm Malignant
1%Pulmonary Embolism
1%Febrile Neutropenia
1%Non-Small Cell Lung Cancer Metastatic
1%Sinus Congestion
1%Embolism Venous
1%Lung Disorder
1%Pulmonary Oedema
1%Atrial Fibrillation
1%Cardiac Failure Congestive
1%Encephalopathy
1%Orthostatic Hypotension
1%Cerebral Haemorrhage
1%Deep Vein Thrombosis
1%Vasculitis
1%Hypoglycaemia
1%Convulsion
1%Haemorrhage Intracranial
1%Blood Alkaline Phosphatase Increased
1%Atrial Flutter
1%Hyponatraemia
1%Transplant Rejection
1%Confusional State
1%Urinary Retention
1%Graft Versus Host Disease
1%Renal Failure Acute
1%Spinal Osteoarthritis
1%Benign Prostatic Hyperplasia
1%Stomatitis
1%Inappropriate Antidiuretic Hormone Secretion
1%Hypercholesterolaemia
0%Hepatitis Acute
0%Colitis
0%Subcutaneous Abscess
0%Rectal Ulcer Haemorrhage
0%Hypersensitivity
0%Abdominal Wall Infection
0%Appendicitis
0%Respiratory Tract Infection
0%Liver Abscess
0%Urinary Tract Infection
0%Wound Infection
0%Mouth Ulceration
0%Pancreatitis
0%Small Intestinal Obstruction
0%Duodenitis Haemorrhagic
0%Inguinal Hernia, Obstructive
0%Ileus
0%Intestinal Obstruction
0%Meniscus Lesion
0%Anastomotic Stenosis
0%Post Procedural Haematoma
0%Foot Fracture
0%Rib Fracture
0%Graft Loss
0%Vascular Pseudoaneurysm
0%Stress Fracture
0%Hepatic Artery Thrombosis
0%Cholangitis
0%Haemobilia
0%Perforation Bile Duct
0%Hepatic Infarction
0%Hernia
0%Fat Tissue Increased
0%Hernia Obstructive
0%Impaired Healing
0%Ulcer Haemorrhage
0%Renal Cell Carcinoma
0%Alveolitis Allergic
0%Iron Deficiency Anaemia
0%Diabetes Mellitus
0%Neuralgic Amyotrophy
0%Neuroleptic Malignant Syndrome
0%Acute Myocardial Infarction
0%Myocardial Infarction
0%Cardiac Arrest
0%Musculoskeletal Pain
0%Mitral Valve Incompetence
0%Alcohol Abuse
0%Ovarian Cyst
0%Liver Transplant Rejection
0%Drug Eruption
0%Cataract
This histogram enumerates side effects from a completed 2008 Phase 4 trial (NCT00118742) in the CellCept + CNI (Tacrolimus or Cyclosporine) ARM group. Side effects include: Diarrhoea with 29%, Abdominal Pain with 18%, Hepatitis C with 16%, Nausea with 16%, Fatigue with 16%.

Trial Design

2 Treatment Groups

Control Arm
1 of 2
Treatment Arm
1 of 2
Active Control
Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Sirolimus · No Placebo Group · Phase 3

Treatment Arm
Drug
Experimental Group · 1 Intervention: Sirolimus · Intervention Types: Drug
Control ArmNoIntervention Group · 1 Intervention: Control Arm · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
2013
Completed Phase 4
~2750

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: The Regional Medical Center/Dialysis Access Institute · Orangeburg, SC
N/AFirst Recorded Clinical Trial
1 TrialsResearching Arteriovenous Fistula
0 CompletedClinical Trials

Eligibility Criteria

Age 65+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.