MEDI3506 for Diabetic Kidney Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetic Kidney DiseaseMEDI3506 - Drug
Eligibility
18 - 101
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it can improve kidney function in people with diabetes.

Eligible Conditions
  • Diabetic Kidney Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: At Day 169, baseline to Day 85 (12 weeks) or Day 85 to Day 169

Week 12
UACR
Week 24
Urine albumin:creatinine ratio (UACR)
Day 230
Immunogenicity of MEDI3506
PK profile of MEDI3506
Day 169
Safety and tolerability by assessment of vital signs
Day 169
: Anti-drug antibodies (ADAs)
Day 85
: Percentage change from baseline
Day 169
: Concentration in plasma
Day 29
: Geometric mean of MEDI3506.
Day 230
Safety and Tolerability by assessment of adverse events
Visit 1(Screening) to End of study
Safety and tolerability by clinical laboratory evaluations

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Dapagliflozin
20%Cervicovaginal infection
13%Urinary tract infections
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT03006471) in the Dapagliflozin ARM group. Side effects include: Cervicovaginal infection with 20%, Urinary tract infections with 13%.

Trial Design

5 Treatment Groups

Group 1
1 of 5
Group 4
1 of 5
Group 2
1 of 5
Group 3
1 of 5
Group 5
1 of 5

Experimental Treatment

Non-Treatment Group

609 Total Participants · 5 Treatment Groups

Primary Treatment: MEDI3506 · Has Placebo Group · Phase 2

Group 1Experimental Group · 2 Interventions: MEDI3506, Dapagliflozin · Intervention Types: Drug, Drug
Group 4Experimental Group · 2 Interventions: MEDI3506, Dapagliflozin · Intervention Types: Drug, Drug
Group 2Experimental Group · 2 Interventions: MEDI3506, Dapagliflozin · Intervention Types: Drug, Drug
Group 3Experimental Group · 2 Interventions: MEDI3506, Dapagliflozin · Intervention Types: Drug, Drug
Group 5PlaceboComparator Group · 2 Interventions: Dapagliflozin, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI3506
2021
Completed Phase 2
~280
Dapagliflozin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at day 169, baseline to day 85 (12 weeks) or day 85 to day 169

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,988 Previous Clinical Trials
91,857,007 Total Patients Enrolled

Eligibility Criteria

Age 18 - 101 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have eGFR 25-75 mL/min/1.73 m2.
You have a stable dose of an ACE inhibitor or an ARB.

Who else is applying?

What state do they live in?
California50.0%
North Carolina50.0%
How old are they?
65+50.0%
18 - 6550.0%
What site did they apply to?
Research Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%