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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study visit - approximately 9 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study visit - approximately 9 hours
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 moreSecondary outcome measures
Dialysate icodextrin biproducts
Serum Glucose monitoring and glucose absorption
Serum Icodextrin biproducts
Side effects data
From 2011 Phase 4 trial • 137 Patients • NCT005674898%
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%
Fluid Imbalance
1%
Cellulitis With Soft Tissue Necrosis Of The Right Hand
1%
Respiratory Tract Infection Viral
1%
Peritonitis By Capd
1%
Cellulitis Of Face
1%
Orchitis
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
656 Previous Clinical Trials
413,418 Total Patients Enrolled
Christopher W McIntyre, MD/PHDPrincipal InvestigatorLondon Health Sciences Centre - Victoria Hospital
1 Previous Clinical Trials
37 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are unable to tolerate maltose or isomaltose.You have a documented problem with the function of the lining of your abdomen, or have extensive scar tissue that affects the function of the lining of your abdomen.You have type 1 diabetes or your diabetes is not well controlled.You currently have an infection that is making you sick.You are allergic to corn starch or icodextrin.You have glycogen storage disease.You have a medical condition that makes it difficult to use the study device or increases the chance of infection.Your blood sodium level is less than 130 mmol/L before the study.Your blood test shows that you have low levels of bicarbonate.You are currently taking medication that only contains a small amount of sugar.You have a working Tenckhoff catheter in place.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What aspirations does this clinical investigation hope to achieve?
"This medical trial, with a duration of 9 hours, will assess Sodium Removal and Ultrafiltration results. Additionally, Serum Icodextrin biproducts (measuring efficacy), Serum and dialysate icodextrin biproducts (efficacy measurement) as well Potassium and bicarbonate removal (efficacy measurement) are secondary outcomes that need to be evaluated throughout the study period."
Answered by AI
Are there vacancies for volunteers in this research endeavor?
"Affirmative. Clinicaltrials.gov displays that this medical trial, which was first listed on October 17th 2022, is searching for qualified participants. A total of 10 patients are needed from two different sites."
Answered by AI
What is the scale of enrollment for this research trial?
"Correct. According to clinicaltrials.gov, this medical study is presently recruiting participants; it was first announced on October 17th 2022 and the most recent update occurred on the same day. The research requires 10 individuals from 2 locations."
Answered by AI
Has the FDA sanctioned this Intervention?
"The safety of Intervention is tentatively rated at 1, due to the nature of this Phase 1 trial. This means there are limited confirmations regarding its efficacy and safety."
Answered by AI
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