Dapagliflozin for Chronic Kidney Disease

Research Site, Senec, Slovakia
Chronic Kidney Disease+1 More ConditionsDapagliflozin - Drug
Eligibility
21 - 130
All Sexes

Study Summary

This trial will compare the effect of a new drug, AZD9977, when used with dapagliflozin, to dapagliflozin used alone, in people with heart failure and chronic kidney disease. The trial will also look at different doses of AZD9977 to see what effect it has.

Eligible Conditions
  • Chronic Kidney Disease
  • Heart Failure

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline (Day 1) until Week 12 (Day 85)

Week 12
Percent change from baseline in UACR at 12 weeks
Percent change from baseline in UACR at 12 weeks to assess dose-response relationship
Day 85
Absolute value of eGFR over time
Absolute value of serum potassium over time
Day 113
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Day 85
Change from baseline in eGFR over time
Change from baseline in serum potassium over time

Trial Safety

Phase-Based Safety

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

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

6 Treatment Groups

AZD9977 Dose C
1 of 6
AZD9977 Dose B + dapagliflozin 10 mg
1 of 6
Dapagliflozin 10 mg
1 of 6
AZD9977 Dose A + dapagliflozin 10 mg
1 of 6
AZD9977 Dose C + dapagliflozin 10 mg
1 of 6
Placebo
1 of 6

Experimental Treatment

Non-Treatment Group

147 Total Participants · 6 Treatment Groups

Primary Treatment: Dapagliflozin · Has Placebo Group · Phase 2

AZD9977 Dose C
Drug
Experimental Group · 1 Intervention: AZD9977 · Intervention Types: Drug
AZD9977 Dose B + dapagliflozin 10 mgExperimental Group · 2 Interventions: Dapagliflozin, AZD9977 · Intervention Types: Drug, Drug
Dapagliflozin 10 mg
Drug
Experimental Group · 1 Intervention: Dapagliflozin · Intervention Types: Drug
AZD9977 Dose A + dapagliflozin 10 mgExperimental Group · 2 Interventions: Dapagliflozin, AZD9977 · Intervention Types: Drug, Drug
AZD9977 Dose C + dapagliflozin 10 mgExperimental Group · 2 Interventions: Dapagliflozin, AZD9977 · Intervention Types: Drug, Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
FDA approved
AZD-9977
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (day 1) until week 12 (day 85)

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,055 Previous Clinical Trials
240,390,993 Total Patients Enrolled
John McMurrayPrincipal InvestigatorUniversity of Glasgow, United Kingdom

Eligibility Criteria

Age 21 - 130 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are not severely obese.

Who else is applying?

What state do they live in?
Texas33.3%
Florida33.3%
Arkansas33.3%
How old are they?
18 - 6550.0%
65+50.0%
What site did they apply to?
Research Site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria66.7%
Met criteria33.3%

Frequently Asked Questions

What is the current population enrolled in this research project?

"Affirmative. Clinicaltrials.gov indicates that this trial, first posted on January 26th 2021, is in the process of recruiting individuals to participate. Altogether, 500 patients must be found from 33 distinct sites for successful completion of the study." - Anonymous Online Contributor

Unverified Answer

Are there any vacant slots remaining in this trial for participants?

"Clinicaltrials.gov confirms that this clinical trial is in the process of recruiting participants, with a post date of January 26th 2021 and an edit on November 22nd 2022." - Anonymous Online Contributor

Unverified Answer

Has Dapagliflozin been explored by other researchers in the past?

"The University of Texas Health Science Center at San Antonio initially conducted research on dapagliflozin in 2014. Presently, there are 18460 completed trials and 63 active ones taking place primarily around Poughkeepsie, New York." - Anonymous Online Contributor

Unverified Answer

Is this a pioneering endeavor in its respective field?

"As of today, Dapagliflozin is a N/A approved drug after its first clinical trial in 2014. Sponsored by AstraZeneca and involving 700 individuals, it has since been studied extensively with 63 active trials conducted across 235 cities and 50 nations." - Anonymous Online Contributor

Unverified Answer

Is this research enrolled individuals of advanced age?

"The requirements for this study indicate that suitable candidates must be aged between 21 and 130. Additionally, there are 68 studies available to those under 18 while 1191 exist specifically tailored towards participants above 65 years of age." - Anonymous Online Contributor

Unverified Answer

Is enrollment currently open to join this research trial?

"Admission to this study requires individuals of ages between 21 and 130 years old that are suffering from cardiac failure. Aspiring participants must be cognizant that 500 spots are available in total." - Anonymous Online Contributor

Unverified Answer

What ailments does Dapagliflozin typically ameliorate?

"Dapagliflozin is frequently prescribed to treat pharmaceutical preparations, but it can also provide benefits for patients with diet-related issues, an exercise regimen that does not yield the desired results, and those who do not respond well to single therapy." - Anonymous Online Contributor

Unverified Answer

Does Dapagliflozin exhibit any potentially dangerous side effects?

"While the efficacy of Dapagliflozin is still uncertain, clinical data does suggest safety, so our team at Power gave it a score of 2." - Anonymous Online Contributor

Unverified Answer

How many health facilities are currently administering this trial in the state?

"At present, 33 medical centres are actively recruiting for this clinical trial. Prospective patients can select from a variety of locations including Poughkeepsie, New Bern and Augusta - to name but a few. It is important to choose the closest site in order to decrease travel requirements if you decide to partake in the study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.