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Osmotic Agent

Icodextrin/Dextrose for Chronic Kidney Disease

Phase 1
Waitlist Available
Led By Christopher W McIntyre, MD/PHD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study visit - approximately 9 hours
Awards & highlights

Study Summary

This trialis looking at how dialysis can safely remove sodium and fluids from kidney failure patients, reducing adverse outcomes. #dialysis #kidneyfailure #sodium #fluidremoval

Eligible Conditions
  • Chronic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study visit - approximately 9 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study visit - approximately 9 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in hemodynamic stability (Blood Pressure)
Changes in hemodynamic stability (Finapres monitoring)
Changes in hemodynamic stability (Heart Rate)
+5 more
Secondary outcome measures
Dialysate icodextrin biproducts
Serum Glucose monitoring and glucose absorption
Serum Icodextrin biproducts

Side effects data

From 2011 Phase 4 trial • 137 Patients • NCT00567489
8%
Hypertension
8%
Oedema Peripheral
8%
Peritonitis
6%
Oedema
6%
Peritonitis Bacterial
5%
Fluid Overload
5%
Anaemia
5%
Nausea
5%
Urinary Tract Infection
5%
Cough
4%
Hypercalcaemia
4%
Catheter Site Infection
3%
Catheter Related Complication
3%
Hypotension
3%
Diarrhoea
3%
Vomiting
3%
Constipation
2%
Fluid Retention
2%
Herpes Zoster
2%
Hypokalaemia
2%
Anxiety
2%
Pruritus
2%
Excessive Granulation Tissue
2%
Insomnia
2%
Electrocardiogram T Wave Inversion
2%
Hyperglycaemia
2%
Angina Pectoris
2%
Dry Eye
2%
Abdominal Pain
2%
Epigastric Pain
2%
Bacterial Peritonitis
2%
Gastroenteritis
2%
Sepsis
2%
Upper Respiratory Tract Infection
2%
Fungal Peritonitis
2%
Gangrene
2%
Lower Respiratory Tract Infection
2%
Decreased Appetite
2%
Dehydration
2%
Diabetic Foot
2%
Gout
2%
Hyperlipidaemia
2%
Hypervolaemia
2%
Hypervolemia
2%
Hypoglycemia
2%
Malnutrition
2%
Moderate Malnutrition
2%
Dizziness
2%
Paraesthesia
2%
Oropharyngeal Pain
2%
Pneumonia
2%
Anemia
2%
Coronary Artery Disease
2%
Hyperparathyroidism
2%
Diarrhea
2%
Incisional Hernia
2%
Flu
2%
Blood Parathyroid Hormone Increased
1%
Orchitis
1%
Cellulitis With Soft Tissue Necrosis Of The Right Hand
1%
Fluid Imbalance
1%
Cellulitis Of Face
1%
Peritonitis By Capd
1%
Respiratory Tract Infection Viral
1%
Blood Urea Increased
1%
Otitis Externa
1%
Blood Magnesium Decreased
1%
Haemoglobin Increased
1%
Severe Acute Respiratory Syndrome
1%
Blood Glucose Abnormal
1%
Arthralgia
1%
Local Infection Of The Skin (Diabetic Sore)
1%
Back Pain
1%
Gouty Arthritis
1%
Accelerated Hypertension
1%
Arteriosclerosis Obliterans
1%
Arterial Stenosis
1%
Diabetic Encephalopathy
1%
Skin Ulcer
1%
Ischaemia
1%
Hypertensive Crisis
1%
Depression
1%
Blood Pressure Inadequately Controlled
1%
Erythema
1%
Acute Myocardial Infarction
1%
Cardiac Failure Acute
1%
Ischemic Heart Disease
1%
Multi-Organ Failure
1%
Cellulitis
1%
Soft Tissue Necrosis
1%
Cervix Carcinoma
1%
Cerebrovascular Accident
1%
Left Atrial Enlargement
1%
Cerumen Impaction
1%
Deafness Neurosensory
1%
Hyperparathyroidism Secondary
1%
Cataract
1%
Eye Haemorrhage
1%
Eye Pain
1%
Glaucoma
1%
Myodesopsia
1%
Visual Acuity Reduced
1%
Abdominal Distension
1%
Diabetic Gastropathy
1%
Gastric Ulcer Haemorrhage
1%
General Physical Health Deterioration
1%
Generalised Oedema
1%
Granuloma
1%
Injection Site Papule
1%
Facial Abscess
1%
Vestibular Neuronitis
1%
Neurotoxicity
1%
Peptic Ulcer
1%
Peritonitis By Cap
1%
Umbilical Hernia
1%
Chest Discomfort
1%
Peritoneal Catheter Dysfunction
1%
Sickness
1%
Sudden Death
1%
Thirst
1%
Thoracic Pain
1%
Cholelithiasis
1%
Exit Site Infection
1%
Syphilis
1%
Tonsillitis
1%
Right Knee Osteoarthritis
1%
Non Specific Thoracic Pain
1%
Gastroenteritis Viral
1%
Cerebral Haemorrhage
1%
Hyperemesis
1%
Cerebral Ischaemia
1%
Diabetic Ulcer
1%
Bloody Peritoneal Effluent
1%
Xerosis
1%
Excoriation On Knees
1%
Fracture Right Leg
1%
St Segment Depression
1%
Urine Output Decreased
1%
Diabetes Mellitus Inadequate Control
1%
Dyslipidaemia
1%
Hypercholesterolaemia
1%
Hyperglycemia
1%
Hyperkalaemia
1%
Hyperphosphatemia
1%
Hypertriglyceridaemia
1%
Hypoalbuminemia
1%
Hypoglycaemia
1%
Hypoproteinaemia
1%
Hyporexia
1%
Polydipsia
1%
Groin Pain
1%
Joint Swelling
1%
Lower Back Pain
1%
Lower Limbs Cramp
1%
Muscle Spasms
1%
Neck Pain
1%
Carcinoid Tumour Of The Duodenum
1%
Burning Sensation
1%
Diabetic Neuropathy
1%
Restless Legs Syndrome
1%
Syncope
1%
Transient Ischaemic Attack
1%
Nephrolithiasis
1%
Bronchospasm
1%
Hiccups
1%
Productive Cough
1%
Rhinorrhoea
1%
Acne
1%
Blister
1%
Hyperkeratosis
1%
Dialysis
1%
Diabetic Vascular Disorder
1%
Haematoma
1%
Abdominal Discomfort
1%
Arteriosclerosis Coronary Artery
1%
Impaired Gastric Emptying
1%
Catheter Site Discharge
1%
Bitten By A Dog On The Left Leg
1%
Blood Alkaline Phosphatase Increased
1%
Blood Calcium Decreased
1%
Wound Infection
1%
Heart Murmur
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non-Glucose Sparing Prescriptions
Glucose Sparing Prescriptions

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Intraperitoneal infusion with 500 mL of sodium-free 30% Icodextrin/ 10% Dextrose solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Icodextrin/Dextrose
2022
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
664 Previous Clinical Trials
414,070 Total Patients Enrolled
Christopher W McIntyre, MD/PHDPrincipal InvestigatorLondon Health Sciences Centre - Victoria Hospital
1 Previous Clinical Trials
37 Total Patients Enrolled

Media Library

Icodextrin (Osmotic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05185999 — Phase 1
Chronic Kidney Disease Research Study Groups: Intervention
Chronic Kidney Disease Clinical Trial 2023: Icodextrin Highlights & Side Effects. Trial Name: NCT05185999 — Phase 1
Icodextrin (Osmotic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05185999 — Phase 1
~4 spots leftby Jun 2025
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