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Monoclonal Antibodies

MEDI3506 for Diabetic Kidney Disease

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
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~day 1, day 29, day 85 and day 169
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 29, day 85 and day 169 for reporting.

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 more
Other study objectives
Plasma Concentration of MEDI3506 - PK Analysis Population

Side effects data

From 2023 Phase 2 trial • 609 Patients • NCT04170543
8%
Hypertension
4%
Covid-19
3%
Back pain
3%
Hyperkalaemia
3%
Upper respiratory tract infection
3%
Diarrhoea
2%
Influenza like illness
2%
Haematoma
2%
Atrial fibrillation
2%
Oedema peripheral
2%
Cough
2%
Headache
2%
Haematuria
2%
Renal cyst
2%
Fall
2%
Hypoglycaemia
2%
Injection site pruritus
1%
Respiratory failure
1%
Acute kidney injury
1%
Abdominal hernia
1%
Peripheral arterial occlusive disease
1%
Pyrexia
1%
Cardiac failure
1%
Diabetic retinopathy
1%
Gout
1%
Muscle spasms
1%
Phimosis
1%
Dermatitis
1%
Corneal disorder
1%
Vitreous floaters
1%
Vomiting
1%
Chest pain
1%
Injection site inflammation
1%
Injection site swelling
1%
Abdominal pain
1%
Ischaemic cardiomyopathy
1%
Diabetic foot
1%
Acute myocardial infarction
1%
Small intestinal obstruction
1%
Injury
1%
Fatigue
1%
Type 2 diabetes mellitus
1%
Anaemia
1%
Ejaculation failure
1%
Ventricular extrasystoles
1%
Lacunar infarction
1%
Skin laceration
1%
Leukocytosis
1%
Viral pharyngitis
1%
Hepatic steatosis
1%
Soft tissue infection
1%
Diabetes mellitus
1%
Pneumonia
1%
Sars-cov-2 test positive
1%
Hypernatraemia
1%
Basal cell carcinoma
1%
Skin cancer
1%
Dizziness
1%
Somnolence
1%
Hypotension
1%
Constipation
1%
Injection site rash
1%
Gangrene
1%
Septic shock
1%
Lung adenocarcinoma
1%
Hyperglycaemia
1%
Acute pulmonary oedema
1%
Acute respiratory failure
1%
Pleural effusion
1%
Influenza
1%
Iatrogenic injury
1%
Blood pressure increased
1%
Malignant melanoma
1%
Gastroenteritis
1%
Sciatica
1%
Chemical burn
1%
Dyspnoea
1%
Pain in extremity
1%
Dysuria
1%
Allergic bronchitis
1%
Ear discomfort
1%
Abdominal pain lower
1%
Iron deficiency anaemia
1%
Vitreous haemorrhage
1%
Cardiac failure congestive
1%
Intestinal obstruction
1%
Candida infection
1%
Pilonidal disease
1%
Skin abrasion
1%
Syncope
1%
Diabetic dermopathy
1%
Retinal haemorrhage
1%
Thrombocytopenia
1%
Renal cell carcinoma
1%
Concussion
1%
C-reactive protein increased
1%
Hyperlipidaemia
1%
Trigger finger
1%
Chronic kidney disease
1%
Pruritus
1%
Thyroid mass
100%
80%
60%
40%
20%
0%
Study treatment Arm
MEDI3506 120 mg
MEDI3506 300 mg
Placebo
MEDI3506 30 mg
MEDI3506 60 mg

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
4,352 Previous Clinical Trials
288,646,200 Total Patients Enrolled
~104 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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