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SGLT2 Inhibitor

Dapagliflozin for Chronic Kidney Disease (ZENITH-CKD Trial)

Phase 2
Waitlist Available
Led By Jamie P. Dwyer, M.D.
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 from week 1 (day 8) until week 12 (day 84)
Awards & highlights

ZENITH-CKD Trial Summary

This trial will study the effects of two drugs, zibotentan and dapagliflozin, either together or separately, in patients with chronic kidney disease.

Eligible Conditions
  • Chronic Kidney Disease

ZENITH-CKD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 1 (day 8) until week 12 (day 84)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 1 (day 8) until week 12 (day 84) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Log-transformed Urinary Albumin to Creatinine Ratio (UACR) from baseline to Week 12
Secondary outcome measures
Change in Blood Pressure from baseline to Week 12
Change in Log-transformed UACR from baseline to Week 12
Change in eGFR from Baseline to Week 1, Week 12 and Week 14
+3 more

ZENITH-CKD Trial Design

3Treatment groups
Experimental Treatment
Group I: Zibotentan Dose B + DapagliflozinExperimental Treatment2 Interventions
Participants will receive once daily oral dose B of zibotentan and 10 mg dapagliflozin for 12 weeks.
Group II: Zibotentan Dose A + DapagliflozinExperimental Treatment2 Interventions
Participants will receive once daily oral dose A of zibotentan and 10 mg dapagliflozin for 12 weeks.
Group III: Placebo + DapagliflozinExperimental Treatment2 Interventions
Participants will receive once daily oral dose of dapagliflozin 10 mg and placebo for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
2014
Completed Phase 4
~64440
Placebo
1995
Completed Phase 3
~2670
Zibotentan
2019
Completed Phase 2
~810

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,262 Previous Clinical Trials
288,593,674 Total Patients Enrolled
Jamie P. Dwyer, M.D.Principal InvestigatorNephrology Clinical Trials Center Nephrology and Hypertension Vanderbilt University Medical Center Nashville TN United States of America
David C Wheeler, MB ChB, MD, FRCPPrincipal InvestigatorCentre for Nephrology Royal Free Campus University College London Rowland Hill Street London NW3 2PF United Kingdom

Frequently Asked Questions

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

Are there any remaining openings for participants in this experiment?

"The data hosted on clinicaltrials.gov attests to this trial's ongoing recruitment of candidates, which was initiated on April 28th 2021 and most recently edited on November 22nd 2022."

Answered by AI

What upper limit has been placed on the number of individuals who may partake in this investigation?

"That is correct. According to the clinicaltrials.gov database, recruitment for this medical trial began on April 28th 2021 and it was last updated on November 22nd 2022. The study requires 495 participants dispersed across 62 different sites."

Answered by AI

What common maladies is Dapagliflozin known to treat?

"Dapagliflozin is commonly prescribed for pharmaceutical preparations and can also aid patients with dietary issues, exercise limitations, or who have had minimal success with monotherapy."

Answered by AI

What types of individuals could qualify for this clinical trial?

"This clinical trial is seeking 495 adults suffering from renal disorders with an eGFR CKD-EPI score of ≥ 20 mL/min/1.73 m^2 and a UACR between 150–5000 mg albumin/g creatinine, based on single morning void spot urine sample collected at the time of screening. Furthermore, no SGLT2i or fixed dose SGLT2i combination treatments should have been received within one month prior to screening; ACEi, ARB, MRA doses must be steady for four weeks preceding the initial assessment; no cytotoxic therapy, immunosuppressive"

Answered by AI

What precedent exists for clinical experimentation involving Dapagliflozin?

"The University of Texas Health Science Center at San Antonio first tested dapagliflozin in 2014 and, since then, 18462 studies have come to completion. Presently, 63 clinical trials are accepting enrollments with many situated in Toronto."

Answered by AI

Is this particular clinical trial unique in its approach or have similar ones been done before?

"Since 2014, AstraZeneca has been studying and sponsoring trials for the drug dapagliflozin. The first trial of 700 participants was completed that year with subsequent N/A approval granted afterwards. Currently there are 63 active medical studies across 235 cities in 50 countries."

Answered by AI

Does this research project accept participants aged below sixty?

"To participate in this study, patients should fall between 18 and 130 years of age. There are 46 trials available to minors while 517 studies target seniors above 65."

Answered by AI

What potential risks should be considered when administering Dapagliflozin to individuals?

"Due to the lack of evidence regarding its efficacy, Dapagliflozin is rated at a 2 on the safety scale. This rating takes into account data collected during Phase 2 trials that point towards it being safe for use."

Answered by AI

How many places are carrying out this research endeavor?

"This trial is currently enrolling participants across 62 different sites. Some of these are situated in Toronto, Winston-Salem and St. John's. It would be wise to select a location closest to you so that any travel required is kept to a minimum if chosen as part of the study."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
California
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Research Site
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Everything is in CA?
PatientReceived no prior treatments

Why did patients apply to this trial?

the fact i canhelp others and the money for the trial.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 1 Day
Most responsive sites:
  1. Research Site: < 24 hours
~138 spots leftby Apr 2025