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TerminatedNCT04492722Updated Dec 20, 2024Results posted

A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease

A Phase 2 interventional study of AZD5718 and Dapagliflozin 10 mg in Chronic Kidney Disease, sponsored by AstraZeneca. Terminated at 111 sites in 11 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Why this study was terminated
The Sponsor decided to terminate the study early due to lack of efficacy. There were no safety concerns related to the study.
Phase
Phase 2
Study type
Interventional
Enrollment
613
Allocation
Randomized
Ages
18 Years to 130 Years
Sex
All
01

Study summary

The purpose of the study is to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease.

Read the detailed description

The study will be conducted in approximately 118 study centers across 12 countries. The overall study period will be around 28 weeks. Approximately 632 participants comprising of 67% diabetic kidney disease (DKD) and 33% non-DKD participants will be enrolled. After a screening period of up to 4 weeks, the participants will be randomised in a 1:1:1:1 ratio to receive one of the doses of AZD5718 and/or placebo for the first 12 weeks (Day 85 [treatment period 1]), with an add-on therapy of 8 weeks of dapagliflozin for all participants from Week 12 to 20 (Day 85 to 141 [treatment period 2]). Only participants still taking their assigned treatment from treatment period 1 will progress to treatment period 2. Any participant with urine albumin to creatinine ratio (ACR) \< 30 mg/g at Week 12 will be excluded from treatment period 2. The eligibility check to enter treatment period 2 will be done at Visit 7 (Week 12) using the last available urine ACR result. The final analysis will be done after all participants have completed follow-up period of up to 4 weeks. The expected total study duration, including the Screening Period, for each participant will be at least 28 weeks.

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • Nephrology
  • Chronic kidney disease
  • Proteinuria
  • Diabetic kidney disease
  • Diabetes mellitus
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 613 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Capable of giving signed informed consent form.
  • Male or female adults, >= 18 years of age at study entry.
  • For participants who haven't reached the age of maturity according to local regulations in their country, a written informed consent should be obtained from the participant and participants legally acceptable representative.
  • Body weight within 50-150 kg and body mass index within the range 18 to 45 kg/m\^2.

  • Participants with proteinuric CKD defined as:

    • eGFR 20 - 75 mL/min/1.73m\^2 based on Chronic Kidney Disease Epidemiology Collaboration equation at Screening Visit 1.
    • Albuminuria defined as 200 -5000 mg albumin/g creatinine based on the geometric mean of the replicated measurements using 3 sequential first morning void urine at Visit 2.
    • Participants with diagnosis of Type 2 Diabetes Mellitus (DM) [for DKD sub-group only].
  • Females of non-childbearing potential must have been surgically sterilized or be postmenopausal, and all female participants must have a negative pregnancy test at screening and prior to study drug administration.
  • Male participants must be surgically sterile or agree to use highly effective contraceptives. Non-sterilized male participants who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from Day 1 to 3 months after the last dose of the study drug. Approved/Certified measurements in Japan are as Vasectomy, tubal occlusion, intrauterine device (provided coils are copper banded), levonorgestrel intrauterine system (eg, Mirena®). These measurements are acceptable forms of highly effective birth control in Japan. Not Approved/Certified measurements in Japan are as: Cerazette® (desogestrel) pills, medroxyprogesterone injections (eg, Depo-Provera®), etonogestrel implants (eg, Implanon®, Norplan®), normal and low dose combined oral pills, norelgestromin/ethinylestradiol transdermal system (eg, Evra® Patch), intravaginal device (eg, NuvaRing®).
  • Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional exploratory genetic research.
  • Participants should have: a) stable blood pressure (BP [BP \<= 150/100 mmHg at Visit 1, and 3]); b)stable dose of angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blockers (ARB) for at least 4 weeks prior to Screening Visit 1; c) participants who have been unable to tolerate ACEi or ARB therapy may be enrolled.
  • Participants must have been on a stable dose for at least 4 weeks prior to Screening Visit 1, who have been on additional antihypertensives (including diuretics); on treatment with drugs with potential to influence albuminuria eg., non-steroidal anti-inflammatory drug; on renin inhibitor or an aldosterone antagonist in combination with an ACEi or an ARB.
  • Participants on Sodium-glucose co-transporter-2 inhibitors (SGLT2i) or Glucagon-like peptide-1 receptor agonist (GLP1-RA) treatment, the participants must have been on a stable dose for at least 4 weeks prior to randomization visit.

Exclusion criteria

Exclusion Criteria:

  • Participants with recent positive hepatitis B or hepatitis C.
  • Diagnosis of polycystic kidney disease or anatomical causes of CKD.
  • Diagnosis of Type 1 DM.
  • Participants with severe hepatic impairment (Child-Pugh class C).
  • Abnormal laboratory findings at Screening Visit 1.

  • Any of the following concomitant conditions or diseases at Screening Visit 1:

    1. History of QT prolongation associated with other medications that required discontinuation of that medication, and congenital long QT syndrome.
    2. Acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting within 6 months.
    3. High degree atrioventricular block II-III, sinus node dysfunction.
    4. Stroke within 3 months, heart failure, and anticipated dialysis or renal transplantation within 1 year.
    5. Any other condition or clinically relevant abnormal findings in physical examination, laboratory results or ECG during screening period.
    6. History of substance dependence or a positive screen for drugs or alcohol abuse. Alcohol and drug screening to be completed for all participants locally with laboratory kits provided by the central laboratory.
  • Participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks of Screening Visit 1.
  • Ongoing use of any biologic drug and/or small molecule targeting the immune system.
  • Any serum creatinine-altering drugs within 1 month prior to Screening Visit 1.
  • Treatment with any concomitant medications known to be associated with Torsades de Pointes or potent inducers/inhibitors of cytochrome P450 3A4 within 4 weeks of Visit 3 (Randomization).
  • Treatment with zileuton, cilastatin (dipeptidase-1 [DPEP1] inhibitor), or leukotriene receptor antagonists (eg, montelukast) within 4 weeks of Screening Visit 1.
  • Treatment with simvastatin, lovastatin, and atorvastatin at doses > 40 mg per day within 1 month prior to Screening Visit 1.
  • Concurrent enrollment in another clinical study involving an investigational treatment or drug or participation in a device study within 3 months prior to Screening Visit 1.
  • Participants with a known hypersensitivity to AZD5718 or any of the excipients of the product. Participants with a known hypersensitivity to dapagliflozin or any of the excipients of the product.
  • Donation of blood or significant blood loss in excess of 500 mL within 3 months prior to Day 1 (or > 1200 mL in the year prior to Day 1).
  • Plasma donation within 60 days prior to Day 1.
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study center).
  • Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
  • For women only - currently pregnant (a negative serum pregnancy test is required at Screening Visit 1 and urine pregnancy test at Day 1 [Visit 3]) or breast-feeding.
  • An employee, or close relative of an employee, of AstraZeneca, the Contract Research Organisation, or the study site, regardless of the employee's role.
  • Participants who are legally institutionalized.
  • Participants working night shifts, and who cannot avoid strenuous manual labour during the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
613 participants (actual)

Study arms

  • Experimental
    AZD5718 Dose 1 + Dapagliflozin 10 mg

    Participants will receive once daily oral dose 1 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Drug: AZD5718 · Drug: Dapagliflozin 10 mg

  • Experimental
    AZD5718 Dose 2 + Dapagliflozin 10 mg

    Participants will receive once daily oral dose 2 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Drug: AZD5718 · Drug: Dapagliflozin 10 mg

  • Experimental
    AZD5718 Dose 3 + Dapagliflozin 10 mg

    Participants will receive once daily oral dose 3 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Drug: AZD5718 · Drug: Dapagliflozin 10 mg

  • Placebo comparator
    Placebo + Dapagliflozin 10 mg

    Participants will receive once daily oral dose of placebo matched to AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Drug: Dapagliflozin 10 mg · Drug: Placebo

Interventions

  • DrugAZD5718

    Participants will receive once daily oral dose of AZD5718 as per the arms they are randomised, and will continue until Week 20.

  • DrugDapagliflozin 10 mg

    Participants will receive once daily oral dose of 10 mg dapagliflozin for 8 weeks as an add-on therapy.

  • DrugPlacebo

    Participants will receive once daily oral dose of placebo matched to AZD5718, and will continue until Week 20.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20

    The dose response effect of AZD5718 on urine ACR at 20 weeks was evaluated. Values less than 1 indicate improvement from baseline.

    Time frame: Week 1 (Baseline) to Week 20

Secondary outcomes

  1. Change From Baseline in Reduction of Urine ACR to Week 12

    The dose response effect of AZD5718 on urine ACR at 12 weeks was evaluated. Values less than 1 indicate improvement from baseline.

    Time frame: Week 1 (Baseline) to Week 12

  2. Number of Participants With Adverse Events and Serious Adverse Events

    The safety and tolerability profile of AZD5718 treatment was assessed

    Time frame: From Screening (Week -4 to 0) to Week 24

  3. Change From Baseline in 24-hours Mean Systolic Blood Pressure to Week 12

    The effect of AZD5718 on ambulatory blood pressure was assessed

    Time frame: Week 1 (Baseline) to Week 12

  4. Plasma Concentrations of AZD5718

    The PK of AZD5718 after repeated oral dosing for 20 weeks was evaluated

    Time frame: From Week 2 to Week 20

  5. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) to Week 12

    The effect of AZD5718 on renal function was evaluated

    Time frame: Week 1 (Baseline), Week 2, Week 4, Week 8, and Week 12

07

Results

Posted Dec 26, 2023
Limitations and caveats
Following study termination and reduced scope of the analysis, the PK analysis has not been performed.

Participant flow

Participants were enrolled in this study from 01 October 2020 to 06 September 2022. The study was terminated early on 01 July 2022 due to lack of efficacy.

Participant flow — Overall Study
MilestoneAZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mg
Started154153153153
Completed72828282
Not completed82717171
Withdrew: Adverse event7230
Withdrew: Death0001
Withdrew: Lost to follow-up0101
Withdrew: Physician decision0311
Withdrew: Withdrawal by subject6603
Withdrew: Development of study specific withdrawal criteria3122
Withdrew: Due to covid-19 pandemic7376
Withdrew: Failure to meet randomisation criteria2342
Withdrew: Early termination from the study54515050
Withdrew: Missing3005
Withdrew: Participants who did not receive treatment0140

Outcome measures

PrimaryChange From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20

The dose response effect of AZD5718 on urine ACR at 20 weeks was evaluated. Values less than 1 indicate improvement from baseline.

Time frame:
Week 1 (Baseline) to Week 20
Reported as:
Geometric mean · milligram/gram (mg/g)
Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20
milligram/gram (mg/g)AZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mg
Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 200.79 (0.69 to 0.90)0.81 (0.70 to 0.92)0.77 (0.67 to 0.87)0.84 (0.73 to 0.95)
SecondaryChange From Baseline in Reduction of Urine ACR to Week 12

The dose response effect of AZD5718 on urine ACR at 12 weeks was evaluated. Values less than 1 indicate improvement from baseline.

Time frame:
Week 1 (Baseline) to Week 12
Reported as:
Geometric mean · mg/g
Change From Baseline in Reduction of Urine ACR to Week 12
mg/gAZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mg
Change From Baseline in Reduction of Urine ACR to Week 120.94 (0.84 to 1.04)1.03 (0.92 to 1.15)0.96 (0.86 to 1.06)1.10 (0.99 to 1.22)
SecondaryNumber of Participants With Adverse Events and Serious Adverse Events

The safety and tolerability profile of AZD5718 treatment was assessed

Time frame:
From Screening (Week -4 to 0) to Week 24
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events and Serious Adverse Events
ParticipantsAZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mg
Any AE828110480
Any AE with outcome = death0001
Any SAE (including events with outcome = death)128116
Any AE leading to discontinuation of study treatment12236
Any AE leading to dose interruption76510
Any AE leading to withdrawal from study7011
Any AE possibly related to study treatment as assessed by investigator1412814
SecondaryChange From Baseline in 24-hours Mean Systolic Blood Pressure to Week 12

The effect of AZD5718 on ambulatory blood pressure was assessed

Time frame:
Week 1 (Baseline) to Week 12
Reported as:
Mean · millimeter mercury (mm Hg)
Change From Baseline in 24-hours Mean Systolic Blood Pressure to Week 12
millimeter mercury (mm Hg)AZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mg
Change From Baseline in 24-hours Mean Systolic Blood Pressure to Week 12-2.06 ± 10.7821.56 ± 11.407-1.83 ± 9.9863.76 ± 11.779
SecondaryPlasma Concentrations of AZD5718

The PK of AZD5718 after repeated oral dosing for 20 weeks was evaluated

Time frame:
From Week 2 to Week 20
Reported as:
Geometric mean · nanomoles per liter (nmol/L)
Plasma Concentrations of AZD5718
nanomoles per liter (nmol/L)AZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mg
Week 2 (pre-dose)4.771 ± 113.04712.181 ± 116.03837.346 ± 138.565
Week 4 (pre-dose)3.975 ± 85.44911.207 ± 111.95137.525 ± 127.660
Week 8 (pre-dose)3.947 ± 77.09711.579 ± 113.40435.903 ± 116.207
Week 12 (pre-dose)4.107 ± 79.06811.041 ± 81.96733.568 ± 127.405
Week 16 (pre-dose)4.115 ± 76.37810.006 ± 97.21635.662 ± 130.148
Week 20 (pre-dose)3.813 ± 65.60510.200 ± 122.27733.063 ± 100.320
Week 4 (post-dose, 1-2 hours)16.321 ± 115.67371.279 ± 128.551340.794 ± 147.394
Week 4 (post-dose, 2-5 hours)18.376 ± 77.40986.464 ± 103.733464.721 ± 79.567
Week 4 (post-dose, 5-8 hours)16.713 ± 65.64876.834 ± 59.503343.531 ± 90.628
Week 4 (post dose, 8-12 hours)14.434 ± 52.41453.706 ± 68.160234.913 ± 97.174
SecondaryChange From Baseline in Estimated Glomerular Filtration Rate (eGFR) to Week 12

The effect of AZD5718 on renal function was evaluated

Time frame:
Week 1 (Baseline), Week 2, Week 4, Week 8, and Week 12
Reported as:
Mean · milliliter/minute/1.73m^2
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) to Week 12
milliliter/minute/1.73m^2AZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mg
Week 2-0.470 ± 6.3936-0.140 ± 5.2801-0.429 ± 5.71750.547 ± 5.7124
Week 4-0.735 ± 6.57640.140 ± 5.2628-0.817 ± 6.19860.058 ± 6.3583
Week 8-0.760 ± 6.0304-0.535 ± 5.8865-1.144 ± 6.5142-0.068 ± 5.3729
Week 12-0.612 ± 6.2138-1.149 ± 6.1783-0.394 ± 6.4678-0.257 ± 6.4508

Adverse events

Collected over From Screening (Week -4 to 0) to Week 24. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AZD5718 Dose 1 + Dapagliflozin 10 mg0/154 (0%)12/154 (7.8%)16/154 (10.4%)
AZD5718 Dose 2 + Dapagliflozin 10 mg0/152 (0%)8/152 (5.3%)8/152 (5.3%)
AZD5718 Dose 3 + Dapagliflozin 10 mg0/149 (0%)11/149 (7.4%)9/149 (6%)
Placebo + Dapagliflozin 10 mg1/153 (0.7%)6/153 (3.9%)8/153 (5.2%)
Most frequent serious events
Showing 10 of 43
Most frequent serious events
EventAZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mg
PneumoniaInfections and infestations1/1540/1522/1490/153
Urinary tract infectionInfections and infestations1/1540/1521/1490/153
COVID-19 pneumoniaInfections and infestations0/1540/1521/1490/153
Septic shockInfections and infestations0/1540/1521/1490/153
Pituitary apoplexyEndocrine disorders0/1540/1521/1490/153
Diabetes mellitusMetabolism and nutrition disorders0/1540/1521/1490/153
Coronary artery diseaseCardiac disorders0/1540/1521/1490/153
Diabetic nephropathyRenal and urinary disorders0/1540/1521/1490/153
Chest painGeneral disorders0/1540/1521/1490/153
Hand fractureInjury, poisoning and procedural complications0/1540/1521/1490/153
Most frequent other events
Most frequent other events
EventAZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mg
HyperkalaemiaMetabolism and nutrition disorders6/1547/1529/1496/153
Urinary tract infectionInfections and infestations8/1548/1521/1496/153
Glomerular filtration rate decreasedInvestigations8/1543/1525/1498/153

Baseline characteristics

All participants who were randomised and received any study treatment were included in the Full Analysis Set (FAS).

Age, Continuous
Age, Continuous(Years)AZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mgTotal
Mean64.9 ± 10.7063.7 ± 10.6365.1 ± 9.3964.3 ± 10.7164.5 ± 10.37
Sex: Female, Male
Sex: Female, Male(Participants)AZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mgTotal
Female57534553208
Male9799104100400
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mgTotal
Hispanic or Latino32372832129
Not Hispanic or Latino122115121121479
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AZD5718 Dose 1 + Dapagliflozin 10 mgAZD5718 Dose 2 + Dapagliflozin 10 mgAZD5718 Dose 3 + Dapagliflozin 10 mgPlacebo + Dapagliflozin 10 mgTotal
American Indian or Alaska Native00000
Asian54555652217
Native Hawaiian or Other Pacific Islander00000
Black or African American2016151566
White68736777285
More than one race00000
Unknown or Not Reported12811940
08

Study locations

111 sites
  • Research Site
    Canoga Park, California 91303, United States
  • Research Site
    La Mesa, California 91942, United States
  • Research Site
    San Carlos, California 94070, United States
  • Research Site
    San Francisco, California 94110, United States
  • Research Site
    Victorville, California 92392, United States
  • Research Site
    Denver, Colorado 80045, United States
  • Research Site
    Jacksonville, Florida 32216, United States
  • Research Site
    Winter Haven, Florida 33880, United States
  • Research Site
    Columbus, Georgia 31904, United States
  • Research Site
    Roseville, Michigan 48066, United States
  • Research Site
    Hazelwood, Missouri 63042, United States
  • Research Site
    Fresh Meadows, New York 11365, United States
  • Research Site
    Great Neck, New York 11021, United States
  • Research Site
    Jamaica, New York 11432, United States
  • Research Site
    Blue Ash, Ohio 45242, United States
  • Research Site
    East Providence, Rhode Island 02914, United States
  • Research Site
    Memphis, Tennessee 38104-2127, United States
  • Research Site
    Austin, Texas 78738, United States
  • Research Site
    Houston, Texas 77099, United States
  • Research Site
    Pearland, Texas 77584, United States
  • Research Site
    San Antonio, Texas 78215, United States
  • Research Site
    Schertz, Texas 78154, United States
  • Research Site
    Bahia Blanca, B8109, Argentina
  • Research Site
    Buenos Aires, 1280, Argentina
  • Research Site
    Cordoba, 5000, Argentina
  • Research Site
    Cordoba, X5016KEH, Argentina
  • Research Site
    Cordoba, X5016KET, Argentina
  • Research Site
    Junín, 6000, Argentina
  • Research Site
    Mar del Plata, B7600, Argentina
  • Research Site
    Belem, 66073-005, Brazil
  • Research Site
    Brasilia, 71625-175, Brazil
  • Research Site
    Curitiba, 80215-901, Brazil
  • Research Site
    Fortaleza, 60430-375, Brazil
  • Research Site
    Meireles, 60160-230, Brazil
  • Research Site
    Porto Alegre, 90035-074, Brazil
  • Research Site
    Porto Alegre, 90430-001, Brazil
  • Research Site
    Santo Andre, 09090-790, Brazil
  • Research Site
    Sao Paulo, 05403-9000, Brazil
  • Research Site
    São Paulo, 01323-020, Brazil
  • Research Site
    São Paulo, 05016-090, Brazil
  • Research Site
    Aschaffenburg, 63739, Germany
  • Research Site
    Berlin, 13509, Germany
  • Research Site
    Essen, 45136, Germany
  • Research Site
    Trier, 54292, Germany
  • Research Site
    Balatonfüred, 8230, Hungary
  • Research Site
    Budapest, 1083, Hungary
  • Research Site
    Budapest, 1115, Hungary
  • Research Site
    Debrecen, 4032, Hungary
  • Research Site
    Szentes, 6600, Hungary
  • Research Site
    Szigetvár, 7900, Hungary
  • Research Site
    Afula, 1834111, Israel
  • Research Site
    Ashdod, 7747629, Israel
  • Research Site
    Ashkelon, 78306, Israel
  • Research Site
    Haifa, 34362, Israel
  • Research Site
    Jerusalem, 91031, Israel
  • Research Site
    Ageo, 362-8588, Japan
  • Research Site
    Asahikawa-shi, 070-8530, Japan
  • Research Site
    Chiba-shi, 261-0004, Japan
  • Research Site
    Hiroshima, 732-0057, Japan
  • Research Site
    Kasugai-shi, 486-8510, Japan
  • Research Site
    Kitakyushu, 805-8508, Japan
  • Research Site
    Koga-shi, 306-0041, Japan
  • Research Site
    Kyoto-shi, 604-8845, Japan
  • Research Site
    Mito-shi, 311-4198, Japan
  • Research Site
    Morioka-shi, 020-0066, Japan
  • Research Site
    Osaka-shi, 530-0005, Japan
  • Research Site
    Osaka-shi, 558-8558, Japan
  • Research Site
    Osaka, 553-0003, Japan
  • Research Site
    Sashima-gun, 306-0433, Japan
  • Research Site
    Shizuoka-shi, 420-8630, Japan
  • Research Site
    Toride-shi, 302-0022, Japan
  • Research Site
    Yokohama-shi, 234-0054, Japan
  • Research Site
    Yokohama-shi, 236-0004, Japan
  • Research Site
    Yokohama-shi, 247-8581, Japan
  • Research Site
    Kota Kinabalu, 88586, Malaysia
  • Research Site
    Kuala Lumpur, 50586, Malaysia
  • Research Site
    Kuala Lumpur, 56000, Malaysia
  • Research Site
    Kuala Lumpur, 59100, Malaysia
  • Research Site
    Malacca, 78300, Malaysia
  • Research Site
    Seremban, 70300, Malaysia
  • Research Site
    Seri Manjung, 32040, Malaysia
  • Research Site
    Sibu, 96000, Malaysia
  • Research Site
    Bialystok, 15-375, Poland
  • Research Site
    Białystok, 15-435, Poland
  • Research Site
    Kraków, 31-559, Poland
  • Research Site
    Oswiecim, 32-600, Poland
  • Research Site
    Rzeszow, 35-055, Poland
  • Research Site
    Łódź, 92-213, Poland
  • Research Site
    Kaohsiung City, 82445, Taiwan
  • Research Site
    Kaohsiung, 833, Taiwan
  • Research Site
    Keelung, 20448, Taiwan
  • Research Site
    New Taipei City, 23148, Taiwan
  • Research Site
    Taichung, 40443, Taiwan
  • Research Site
    Taichung, 40705, Taiwan
  • Research Site
    Taichung, 433, Taiwan
  • Research Site
    Taipei 112, Taiwan
  • Research Site
    Taipei, 100, Taiwan
  • Research Site
    Taipei, 116, Taiwan
  • Research Site
    Dnipro, 49005, Ukraine
  • Research Site
    Dnipro, 49038, Ukraine

Showing the first 100 of 111 sites across 11 countries.

09

References and documents

Publications

  • Heerspink HJL, Law G, Psachoulia K, Connolly K, Whatling C, Ericsson H, Knochel J, Lindstedt EL, MacPhee I. Design of FLAIR: a Phase 2b Study of the 5-Lipoxygenase Activating Protein Inhibitor AZD5718 in Patients With Proteinuric CKD. Kidney Int Rep. 2021 Aug 27;6(11):2803-2810. doi: 10.1016/j.ekir.2021.08.018. eCollection 2021 Nov. PubMed 34805632 ↗

Study documents

  • Study protocol · Jan 25, 2021
  • Statistical analysis plan · Nov 26, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04492722
Lead sponsor
AstraZeneca
Collaborators
Parexel, George Clinical Pty Ltd
Responsible party
Sponsor
First posted
Jul 30, 2020
Start date
Oct 1, 2020
Primary completion
Sep 6, 2022
Completion
Sep 6, 2022
Results posted
Dec 26, 2023
Last update
Dec 20, 2024

Study contacts

Hiddo J. L. Heerspink
principal investigator · Department of Clinical Pharmacy and Pharmacology University Medical Centre Groningen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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