Chronic Kidney Disease (CKD)Phase 2TACTIC-CKDNCT07911124
Ticagrelor for Inflammation and Cardiovascular Risk in Patients With Chronic Kidney Disease
A Phase 2 study testing Ticagrelor: an oral, direct-acting, reversibly binding P2Y12 receptor antagonist in people with Chronic Kidney Disease (CKD), run by University of Arkansas at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if treatment with ticagrelor tablets can decrease inflammation in patients with Chronic Kidney Disease (CKD). Inflammation is thought to contribute to the risk of heart disease which is the leading cause of death in patients with CKD. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- Ticagrelor: an oral, direct-acting, reversibly binding P2Y12 receptor antagonist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jul 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Population 1: CKD Participants
- Provision of signed and dated written informed consent.
- Age 21 to 75 years at the time of screening, inclusive.
- Diagnosis of chronic kidney disease with estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m² as calculated by the CKD-EPI equation, confirmed from medical records or laboratory results.
- Currently receiving the maximally tolerated or labeled dose of a renin-angiotensin-aldosterone system inhibitor (RAASi) as guideline-directed medical therapy (GDMT), or documentation of the reason for not receiving RAASi (e.g., intolerance, contraindication).
- Population 2: Control Participants
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- Provision of signed and dated written informed consent.
- Age 21 to 75 years at the time of screening, inclusive.
- Normal kidney function, defined as eGFR >60 ml/min/1.73m² (CKD-EPI equation) and urinary albumin-to-creatinine ratio (UACR) <30 mg/g, confirmed from medical records or laboratory results.
Who cannot join
- Population 1: CKD Participants
- Unwilling or unable to participate in the protocol or comply with its components.
- End-stage renal disease (defined as receiving peritoneal dialysis or hemodialysis) or any prior solid organ or bone marrow transplant. Rationale: dialysis directly affects platelet function and would confound the primary endpoint.
- Acute kidney injury superimposed on CKD at the time of screening.
- Acute coronary syndrome, acute myocardial infarction, or acute cerebrovascular event within 6 months prior to screening. Rationale: these participants are likely receiving P2Y12 inhibitor therapy, and their enrollment would confound the primary endpoint.
- Hospitalization, major surgery, or use of systemic antibiotics within 1 month prior to screening. Rationale: these events are potentially associated with acute inflammatory changes that would confound baseline cytokine measurements.
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- Blood dyscrasias, active bleeding of any site, or a known bleeding diathesis.
- History of gastrointestinal bleeding within 6 months prior to screening.
- Concomitant use of any antiplatelet agent other than aspirin (e.g., clopidogrel, prasugrel, dipyridamole) or any antithrombotic or anticoagulant medication (e.g., warfarin, direct oral anticoagulants) at the time of screening or anticipated need during the study period.
- Hemoglobin <8 g/dL, white blood cell count >20,000/μL, or platelet count <50,000/μL at the time of screening.
- Any active malignancy requiring systemic treatment, or chronic liver disease (including cirrhosis or hepatitis with active inflammation).
- Current use of immunosuppressive medications (e.g., corticosteroids, calcineurin inhibitors, mycophenolate). Rationale: these medications independently alter cytokine profiles and leukocyte gene expression, confounding the primary and mechanistic endpoints.
- Age older than 75 years. Rationale: individuals older than 75 years carry a substantially higher risk of bleeding on antiplatelet therapy and are excluded for participant safety.
- Pregnancy or breastfeeding at the time of screening or plans to become pregnant during the study period. Women of reproductive potential will undergo a urine pregnancy test at screening (Visit 1); a positive result excludes from participation.
- Known severe hypersensitivity or allergy to ticagrelor or any component of the study drug formulation.
- Treatment with another investigational drug or other intervention ongoing, or within a month of randomization.
- Ongoing treatment for infection.
- Population 2: Control Participants
- Any known diagnosis of chronic kidney disease, eGFR ≤60 ml/min/1.73m², or UACR ≥30 mg/g.
- Inability to sign consent and HIPAA form. Legal Authorized Representatives are not allowed to sign the consent form.
- Unwillingness or inability to participate in the protocol or comply with any of its components.
- Any current use of aspirin or NSAIDs and not willing to hold.
- Current use of antibiotics or ongoing infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Jonathan Young, 501-526-7984, jayoung@uams.edu
David Avery, 501-214-2101, DAAvery@uams.edu
About this study
Official title: A Randomized Double-Blind Placebo-Controlled Phase II Clinical Trial to Investigate the Effect of Platelet Inhibition With Ticagrelor to Reduce Inflammation and Surrogate Cardiovascular Markers in Chronic Kidney Disease
The goal of this clinical trial is to learn if treatment with ticagrelor tablets can decrease inflammation in patients with Chronic Kidney Disease (CKD). Inflammation is thought to contribute to the risk of heart disease which is the leading cause of death in patients with CKD. Decreasing inflammation may decrease the risk of heart disease.
The main questions it aims to answer are:
Read more
- Why are patients with CKD at increased risk for heart disease and how to reduce that risk in the future.
- If there could be new treatment options for managing inflammation in blood of patients with CKD.
Researchers will compare Ticagrelor to a Placebo (a look-alike substance that contains no drug) to see if ticagrelor decreases inflammation in adult patients with CKD. A comparator (control) group not receiving the drug/placebo will consist of adults without CKD.
Participants with CKD will:
- Take ticagrelor 90 mg or placebo orally twice daily for 42 days
- Visit the clinic once every 2 weeks for checkups, tests, and bloodwork
- Participation will last approximately 12 weeks
Participants without CKD (control group) will visit the clinic twice (7 weeks apart) to provide information and bloodwork. Participation will last approximately 7 weeks with additional optional visits.
Read the detailed description
This randomized, double-blind, placebo-controlled trial tests the hypothesis that platelet inhibition with ticagrelor, a P2Y12 receptor antagonist, will reduce serum inflammatory cytokine levels and improve surrogate cardiovascular (CV) markers in adult patients with chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m² who do not have a CV indication for antiplatelet therapy. The primary endpoint is serum IL-1β at Day 42 vs. baseline.
A parallel mechanistic arm will characterize leukocyte gene expression changes induced by P2Y12 antagonism using bulk RNA sequencing and will elucidate the molecular mechanisms by which CKD platelets alter leukocyte secretory function via P2Y12 receptors through in vitro co-culture studies.
The primary objective is to determine whether ticagrelor monotherapy decreases serum IL-1β and other inflammatory cytokines in patients with CKD (eGFR <45 ml/min/1.73m²) who do not have a CV indication for antiplatelet therapy, and to evaluate the clinical relevance of this cytokine reduction on surrogate markers of CV risk.
The secondary objectives focus on genomics and mechanistic work on samples obtained from patients with CKD. Samples from a comparator group of controls without CKD will be used for better interpretation of the results.
Aim 1 (CKD Participants): N = 180 adults with CKD; eGFR <45 ml/min/1.73m² (CKD-EPI equation); age 21-75 years; both sexes; all racial/ethnic backgrounds; receiving maximally tolerated or labeled dose of renin-angiotensin-aldosterone system inhibitors (RAASi) as guideline-directed medical therapy (GDMT); not receiving dialysis. Randomized 1:1 to ticagrelor (N=90) or placebo (N=90).
Aim 2 (Control Participants): N = 50 adults without CKD; eGFR >60 ml/min/1.73m²; UACR <30 mg/g; age 21-75 years; frequency-matched to CKD participants by decade of age, sex, and race. No study intervention administered.
Ticagrelor (P2Y12 receptor antagonist), 90 mg orally twice daily (BID), administered as encapsulated tablets for 42 days; or matching placebo, identically encapsulated, orally twice daily for 42 days. Study drug is added on top of maximally tolerated RAASi therapy (guideline-directed medical therapy/GDMT). Baseline use of aspirin is captured as a stratification variable for randomization. No changes to GDMT dose are permitted during the intervention period unless required for participant safety. Control participants receive no study intervention.
- Conditions
- Chronic Kidney Disease (CKD)
- Being tested
- Ticagrelor: an oral, direct-acting, reversibly binding P2Y12 receptor antagonist, Placebo
- Keywords
- Chronic Kidney Disease, CKD, Ticagrelor, Inflammation
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor: an oral, direct-acting, reversibly binding P2Y12 receptor antagonistDrug
Ticagrelor 90 mg orally twice daily for 42 days
PlaceboDrug
Placebo orally twice daily for 42 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Ticagrelor for adults with CKD | Experimental | Ticagrelor 90 mg orally twice daily for 42 days Receives: Drug: Ticagrelor: an oral, direct-acting, reversibly binding P2Y12 receptor antagonist |
| Arm 2 - Placebo for adults with CKD | Placebo comparator | Placebo orally twice daily for 42 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: post-treatment IL-1β value
Blood (Serum IL-1β) will be drawn at baseline (Day 0) and post-treatment (Day 42) and analyzed to determine if mean reduction in IL-1β is significantly higher in the ticagrelor arm than the placebo arm. To determine the clinical relevance of this cytokine reduction on surrogate markers of cardiovascular risk.
Measured: from baseline (day 0) to post-treatment (day 42)
Secondary outcomes (1)
Aim 1: effect of ticagrelor on additional markers
Will evaluate the effect of ticagrelor monotherapy on additional inflammatory markers, surrogate cardiovascular markers, and safety outcomes in CKD patients after 42 days of treatment. Will determine whether the anti-inflammatory effects of ticagrelor persist after a 30-day drug washout period (Day 72) by comparing serum cytokine levels and UACR at Day 72 to Day 0 in the ticagrelor arm.
Measured: from baseline (day 0) to post-treatment (day 42) for additional markers, and to day 72 for washout analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nishank Jain, M.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911124
- Sponsor's protocol ID
- 300167
- Other IDs
- 1R01HL187306-01
- Acronym
- TACTIC-CKD
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Phase II Clinical Trial to Investigate the Effect of Platelet Inhibition With Ticagrelor to Reduce Inflammation and Surrogate Cardiovascular Markers in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07911124
- Acronym / sponsor ID
- TACTIC-CKD / 300167
- Conditions
- Chronic Kidney Disease (CKD)
- Keywords
- Chronic Kidney Disease, CKD, Ticagrelor, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if treatment with ticagrelor tablets can decrease inflammation in patients with Chronic Kidney Disease (CKD). Inflammation is thought to contribute to the risk of heart disease which is the leading cause of death in patients with CKD. Decreasing inflammation may decrease the risk of heart disease.
The main questions it aims to answer are:
- Why are patients with CKD at increased risk for heart disease and how to reduce that risk in the future.
- If there could be new treatment options for managing inflammation in blood of patients with CKD.
Researchers will compare Ticagrelor to a Placebo (a look-alike substance that contains no drug) to see if ticagrelor decreases inflammation in adult patients with CKD. A comparator (control) group not receiving the drug/placebo will consist of adults without CKD.
Participants with CKD will:
- Take ticagrelor 90 mg or placebo orally twice daily for 42 days
- Visit the clinic once every 2 weeks for checkups, tests, and bloodwork
- Participation will last approximately 12 weeks
Participants without CKD (control group) will visit the clinic twice (7 weeks apart) to provide information and bloodwork. Participation will last approximately 7 weeks with additional optional visits.
Detailed description
This randomized, double-blind, placebo-controlled trial tests the hypothesis that platelet inhibition with ticagrelor, a P2Y12 receptor antagonist, will reduce serum inflammatory cytokine levels and improve surrogate cardiovascular (CV) markers in adult patients with chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m² who do not have a CV indication for antiplatelet therapy. The primary endpoint is serum IL-1β at Day 42 vs. baseline.
A parallel mechanistic arm will characterize leukocyte gene expression changes induced by P2Y12 antagonism using bulk RNA sequencing and will elucidate the molecular mechanisms by which CKD platelets alter leukocyte secretory function via P2Y12 receptors through in vitro co-culture studies.
The primary objective is to determine whether ticagrelor monotherapy decreases serum IL-1β and other inflammatory cytokines in patients with CKD (eGFR <45 ml/min/1.73m²) who do not have a CV indication for antiplatelet therapy, and to evaluate the clinical relevance of this cytokine reduction on surrogate markers of CV risk.
The secondary objectives focus on genomics and mechanistic work on samples obtained from patients with CKD. Samples from a comparator group of controls without CKD will be used for better interpretation of the results.
Aim 1 (CKD Participants): N = 180 adults with CKD; eGFR <45 ml/min/1.73m² (CKD-EPI equation); age 21-75 years; both sexes; all racial/ethnic backgrounds; receiving maximally tolerated or labeled dose of renin-angiotensin-aldosterone system inhibitors (RAASi) as guideline-directed medical therapy (GDMT); not receiving dialysis. Randomized 1:1 to ticagrelor (N=90) or placebo (N=90).
Aim 2 (Control Participants): N = 50 adults without CKD; eGFR >60 ml/min/1.73m²; UACR <30 mg/g; age 21-75 years; frequency-matched to CKD participants by decade of age, sex, and race. No study intervention administered.
Ticagrelor (P2Y12 receptor antagonist), 90 mg orally twice daily (BID), administered as encapsulated tablets for 42 days; or matching placebo, identically encapsulated, orally twice daily for 42 days. Study drug is added on top of maximally tolerated RAASi therapy (guideline-directed medical therapy/GDMT). Baseline use of aspirin is captured as a stratification variable for randomization. No changes to GDMT dose are permitted during the intervention period unless required for participant safety. Control participants receive no study intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Ticagrelor for adults with CKD | Experimental | Drug: Ticagrelor: an oral, direct-acting, reversibly binding P2Y12 receptor antagonistTicagrelor 90 mg orally twice daily for 42 days |
| Arm 2 - Placebo for adults with CKD | Placebo comparator | Drug: PlaceboPlacebo orally twice daily for 42 days |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Population 1: CKD Participants
- Provision of signed and dated written informed consent.
- Age 21 to 75 years at the time of screening, inclusive.
- Diagnosis of chronic kidney disease with estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m² as calculated by the CKD-EPI equation, confirmed from medical records or laboratory results.
- Currently receiving the maximally tolerated or labeled dose of a renin-angiotensin-aldosterone system inhibitor (RAASi) as guideline-directed medical therapy (GDMT), or documentation of the reason for not receiving RAASi (e.g., intolerance, contraindication).
Key exclusion criteria (23 listed)
- Population 1: CKD Participants
- Unwilling or unable to participate in the protocol or comply with its components.
- End-stage renal disease (defined as receiving peritoneal dialysis or hemodialysis) or any prior solid organ or bone marrow transplant. Rationale: dialysis directly affects platelet function and would confound the primary endpoint.
- Acute kidney injury superimposed on CKD at the time of screening.
- Acute coronary syndrome, acute myocardial infarction, or acute cerebrovascular event within 6 months prior to screening. Rationale: these participants are likely receiving P2Y12 inhibitor therapy, and their enrollment would confound the primary endpoint.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor: an oral, direct-acting, reversibly binding P2Y12 receptor antagonistTicagrelor 90 mg orally twice daily for 42 days | Drug | Arm 1 - Ticagrelor for adults with CKD |
| PlaceboPlacebo orally twice daily for 42 days | Drug | Arm 2 - Placebo for adults with CKD |
Primary outcome
Aim 1: post-treatment IL-1β value
Time frame: from baseline (day 0) to post-treatment (day 42)
Blood (Serum IL-1β) will be drawn at baseline (Day 0) and post-treatment (Day 42) and analyzed to determine if mean reduction in IL-1β is significantly higher in the ticagrelor arm than the placebo arm. To determine the clinical relevance of this cytokine reduction on surrogate markers of cardiovascular risk.
1 secondary outcome
Aim 1: effect of ticagrelor on additional markers
Time frame: from baseline (day 0) to post-treatment (day 42) for additional markers, and to day 72 for washout analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nishank Jain, M.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ticagrelor: an oral, direct-acting, reversibly binding P2Y12 receptor antagonist in people with Chronic Kidney Disease (CKD), run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Young (501-526-7984, jayoung@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: post-treatment IL-1β value (time frame: from baseline (day 0) to post-treatment (day 42)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.