Your session is about to expire
← Back to Search
Monoclonal Antibodies
A Phase 2b Diabetic Kidney Disease Study
Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
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 day 1, day 29, day 85 and day 169
Summary
This trial is testing a new drug called MEDI3506 to help adults with diabetic kidney disease. The drug aims to reduce protein in the urine and improve kidney function. It is being tested on patients who may not fully respond to standard treatments.
Eligible Conditions
- Diabetic Kidney Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 29, day 85 and day 169
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 29, day 85 and day 169
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population
Secondary study objectives
Asymptomatic Participants Tested Positive for COVID-19 During the Study - Safety Analysis Population
Immunogenicity of MEDI3506 - PK Analysis Population
Percent Change From Baseline to Day 169 (Week 24) in UACR - Full Analysis Population
+6 moreOther study objectives
Plasma Concentration of MEDI3506 - PK Analysis Population
Side effects data
From 2023 Phase 2 trial • 609 Patients • NCT041705436%
Hyperkalaemia
4%
Diarrhoea
4%
Urinary tract infection
3%
Covid-19
3%
Peripheral swelling
2%
Abdominal pain upper
2%
Constipation
2%
Pruritus
2%
Muscle spasms
2%
Nasopharyngitis
2%
Back pain
1%
Joint effusion
1%
Pain in extremity
1%
Cholecystitis acute
1%
Diverticulum intestinal
1%
Vomiting
1%
Pneumonia aspiration
1%
Renal impairment
1%
Musculoskeletal chest pain
1%
Orthopnoea
1%
Injection site inflammation
1%
Infected dermal cyst
1%
Asthenia
1%
Troponin increased
1%
Hypertension
1%
Bile duct stone
1%
Intervertebral disc degeneration
1%
Fungal skin infection
1%
Bleeding varicose vein
1%
Colitis microscopic
1%
C-reactive protein increased
1%
Dyspnoea
1%
Oedema peripheral
1%
Hypokalaemia
1%
Gastritis erosive
1%
Toothache
1%
Pharyngitis
1%
Cellulitis
1%
Cardio-respiratory arrest
1%
Metabolic acidosis
1%
Hypovolaemia
1%
Foot deformity
1%
Faecaloma
1%
Vaccination complication
1%
Brain natriuretic peptide increased
1%
Weight increased
1%
Vitamin d deficiency
1%
Restless legs syndrome
1%
Acute kidney injury
1%
Coronary artery disease
1%
Decreased appetite
1%
Sleep apnoea syndrome
1%
Drug hypersensitivity
1%
Cardiac failure
1%
Type 2 diabetes mellitus
1%
Gastric polyps
1%
Septic shock
1%
Hypervolaemia
1%
Pancreatitis
1%
Head injury
1%
Hypothyroidism
1%
Cataract
1%
Hypernatraemia
1%
Muscle fatigue
1%
Fall
1%
Abdominal pain
1%
Blood glucose increased
1%
Gastrooesophageal reflux disease
1%
Spinal stenosis
1%
Rash macular
1%
Folliculitis
1%
Dry skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
MEDI3506 60 mg
MEDI3506 300 mg
MEDI3506 120 mg
MEDI3506 30 mg
Placebo
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 4Experimental Treatment2 Interventions
MEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168).
Group II: Group 3Experimental Treatment2 Interventions
MEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168).
Group III: Group 2Experimental Treatment2 Interventions
MEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168).
Group IV: Group 1Experimental Treatment2 Interventions
MEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168).
Group V: Group 5Placebo Group2 Interventions
Placebo (volume matched) plus Dapagliflozin (Day 85 to Day 168).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI3506
2021
Completed Phase 2
~1270
Dapagliflozin
2014
Completed Phase 4
~64440
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,122,984 Total Patients Enrolled