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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 at day 169, baseline to day 85 (12 weeks) or day 85 to day 169
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 169, baseline to day 85 (12 weeks) or day 85 to day 169
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 169, baseline to day 85 (12 weeks) or day 85 to day 169 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urine albumin:creatinine ratio (UACR)
Secondary outcome measures
Immunogenicity of MEDI3506
Safety and Tolerability by assessment of adverse events
Safety and tolerability by clinical laboratory evaluations
+1 more
Other outcome measures
: Anti-drug antibodies (ADAs)
: Concentration in plasma
: Geometric mean of MEDI3506.
+2 more

Side effects data

From 2022 Phase 2 trial • 148 Patients • NCT04212169
11%
Dermatitis atopic
5%
Aphthous ulcer
5%
Nausea
5%
Liver function test increased
5%
Dermatitis infected
5%
Folliculitis
5%
Gamma-glutamyltransferase increased
5%
Hypotension
5%
Carpal tunnel syndrome
5%
Acarodermatitis
5%
Oral herpes
5%
Nasopharyngitis
5%
Urine analysis abnormal
5%
Headache
5%
Presyncope
5%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
MEDI3506 Dose 1
MEDI3506 Dose 2
MEDI3506 Dose 3

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
~64880

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,470,812 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many areas are executing the trial in this urban center?

"At present, 56 medical centres are enrolling patients in this trial. These locations include Atlanta, Wichita and Huntsville along with many others. To reduce the burden of travel, it is best to select a clinic nearest to you if considering participation."

Answered by AI

What potential risks accompany the use of MEDI3506?

"MEDI3506's safety has been partially validated, so it was awarded a score of 2 on our scale. As this is only a Phase 2 trial, no efficacy data exists yet."

Answered by AI

Are octogenarians included in this clinical investigation?

"For this clinical trial, participants must be aged 18-101. Separately, there are 45 trials available to minors and 503 studies open to elderly individuals."

Answered by AI

Is this the pioneering endeavor of its type?

"MEDI3506 was first examined in 2014 by AstraZeneca, with a 700-person trial leading to its N/A drug approval. Nowadays, MEDI3506 is featured in 63 separate trials across 235 cities and 50 countries worldwide."

Answered by AI

Have any other investigations taken place that involve MEDI3506?

"MEDI3506 was initially researched in 2014 at the University of Texas Health Science Center located in San Antonio. To date, 18453 clinical trials have been concluded with 63 currently active studies, a majority of which are being conducted out of Atlanta, Georgia."

Answered by AI

Am I qualified to partake in this clinical trial?

"This medical experiment is searching for 609 individuals, aged 18 to 101, suffering from kidney diseases. The primary requirements are that they have type-2 diabetes, an estimated glomerular filtration rate between 25 and 75 mL/min/1.73 m2, a urinary albumin creatinine ratio of 100 to 3000 mg albumin/g creatinine, blood pressure lower than 150 over 100 mmHG, and a stable dose of ACE inhibitors or angiotensin receptor blockers (ARBs)."

Answered by AI

What is the typical purpose of MEDI3506?

"MEDI3506 offers therapeutic solutions to address pharmaceuticals, dietary requirements and physical activity."

Answered by AI

Is enrollment currently open for this clinical trial?

"According to clinicaltrials.gov, this trial is not presently recruiting patients and the most recently modified version of the posting was on October 20th 2022. In spite of this fact, there are 547 other medical studies that require human participants at present."

Answered by AI

What is the participant capacity of this research endeavor?

"At present, this clinical trial is not recruiting. Initially posted on the 18th of November 2019 and most recently updated on October 20th 2022, it is currently inactive. However, there are presently 484 studies actively seeking patients with kidney diseases and 63 trials for MEDI3506 which are open to new participants."

Answered by AI

Who else is applying?

What state do they live in?
California
North Carolina
How old are they?
65+
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~114 spots leftby Mar 2025