Kidney CancerPhase 2NCT05487859
Acarbose in Combination With Standard Therapy in Metastatic Renal Cell Carcinoma (RCC)
A Phase 2 study testing Acarbose Tablets in people with Kidney Cancer, run by University of Alabama at Birmingham.
Trial summary
The purpose of this study is to determine the safety and tolerability of acarbose in combination of immunotherapy based standard of care therapy in advanced renal cell carcinoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Acarbose Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of clear cell or non-clear cell carcinoma of the kidney, except for medullary carcinoma, collecting duct carcinoma, lymphoma and sarcoma. Sarcomatoid features of any degree are allowed
- Must have locally advanced or unresectable metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease.
- Has measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist.
- Has received no prior systemic therapy for advanced RCC in the past 3 weeks.
- Has Karnofsky performance status (KPS) ≥ 60% as assessed within 10 days prior to randomization.
- If receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization.
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- Demonstrates adequate organ function defined as follows
- Liver function liver function (bilirubin < 3mg/dL, AST and/or ALT <3 x ULN)
- Kidney function (CrCL >=15ml/min using cockroft-gault method)
- ANC >= 500/microliter, Hemoglobin > 8 mg/dL, platelet count > 50,000/microliter
- CNS metastasis is allowed if has been treated >3 weeks and patient has achieved clinical stability with no new neurologic deficits in the interim
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drugs. Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.
Who cannot join
- 1. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization.
- 2. Has had major surgery within 4 weeks, received radiation therapy within 2 weeks prior to randomization, or has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to prior treatment.
- 3. Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to acarbose or investigators choice of standard of care therapy.
- 4. Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding physiologic corticosteroid dose or any other form of immunosuppressive therapy within 7 days prior to randomization, except in the case of central nervous system (CNS) metastases.
- 5. Has an active autoimmune disease requiring systemic treatment with in the past 2 years OR a documented history of clinically severe autoimmune disease. Note: Participants with vitiligo, Sjøgren's syndrome, Type 1 diabetes, resolved childhood asthma/atopy, hypothyroidism or adrenal or pituitary insufficiency who are stable on hormone replacement, are not excluded.
- 6. Has a known additional malignancy that has progressed or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer in situ are acceptable if they have undergone potentially curative therapy. Low grade prostate cancer with gleason score 6 or lower which is not under active therapy will be acceptable if in investigator judgement it is likely not a competing risk to patient's life expectancy.
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- 7. Has known active untreated CNS metastases and/or carcinomatous meningitis. 8. Has an active infection requiring systemic therapy. 9. Has received a live virus vaccine within 30 days of randomization. 10. Has a clinically significant gastrointestinal (GI) abnormality including Malabsorption, total gastric resection or any condition that might affect the absorption of orally taken medication.
- 11. Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy 12. Has QT interval corrected for heart rate (QTc) ≥480 msec. 13. Has a history of any of the following cardiovascular conditions within 6 months of randomization: Myocardial infarction, Unstable angina pectoris Cardiac angioplasty or stenting, Coronary/peripheral artery bypass graft, Class III or IV congestive heart failure per New York Heart Association and Cerebrovascular accident or transient ischemic attack.
- 14. Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg measured two times a day - despite the use of 3 or more antihypertensive medications.
- 15. Has recorded hypoglycemic episodes with blood glucose <60 mg/dL documented within the last 12 months.
- 16. Has medication treated diabetes and HbA1c < 8 gm/dL 17. Has hemoptysis within 6 weeks prior to randomization. 18. Has current use (within 7 days of randomization) or anticipated need for treatment with drugs or foods that are known strong cytochrome P450 (CYP3A4/5) inhibitors.
- 19. Has current use (within 7 days of randomization) or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort; or drugs that are known with proarrhythmic potential.
- 20. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- 21. Has had a prior solid organ transplant. 22. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.
About this study
Official title: A Pilot Study of the Immunomodulatory Agent Acarbose in Combination With Standard Therapy in Metastatic Renal Cell Carcinoma (RCC)
The purpose of this study is to determine the safety and tolerability of acarbose in combination of immunotherapy based standard of care therapy in advanced renal cell carcinoma patients.
- Conditions
- Kidney Cancer
- Being tested
- Acarbose Tablets
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acarbose TabletsDrug
Acarbose Tablets PO ranging from 25 mg initially to 100 mg as tolerated
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Ipilimumab (1 mg/kg) IV q3wks + Nivolumab (3mg/kg) IV q3wks + Acarbose (upto 100 mg PO TID) followed by Nivolumab 480 mg IV q4 wks + Acarbose (upto 100 mg PO TID)
OR
Pembrolizumab 200 mg IV q3 wks or 400 mg IV q6 wks + Lenvatinib (up to 20 mg PO Daily) + Acarbose (upto 100 mg PO TID) [ Frontline/Refractory pts]
OR
Lenvatinib (upto 18 mg PO daily) + Everolimus (upto 5 mg PO Daily) + Acarbose (upto 100 mg PO TID) [ Refractory pts]
OR
Cabozantinib (upto 60 mg PO Daily) + Acarbose (upto 100 mg PO TID) [Refractory pts] Receives: Drug: Acarbose Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety profile of acarbose in addition to standard of care (SOC) treatment in RCC
adverse events will be defined and assessed using the National Cancer Institute's Common Terminology Criteria (CTCAE) v5.0
Measured: 2 years
To assess the effect of acarbose on the gut microbiome in patients receiving as standard of care therapy.
Fecal microbiota populations will be characterized prior, during and after treatment with acarbose.
Measured: 2 years
Secondary outcomes (2)
To assess the efficacy of Acarbose in combination with SOC treatment in RCC
Estimate of the median progression free survival (mPFS) of patients treated with SOC + Acarbose
Measured: 2 years
To assess the efficacy of Acarbose in combination with SOC treatment in RCC
Estimate of the median overall survival (mOS) of patients treated with SOC + Acarbose
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start31 Dec 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: due to overall cost of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnab Basu, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487859
- Sponsor's protocol ID
- UAB23143
- Status last verified
- Feb 2026
- First submitted
- 2 Aug 2022
- Last updated
- 17 Feb 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Immunomodulatory Agent Acarbose in Combination With Standard Therapy in Metastatic Renal Cell Carcinoma (RCC)
- ClinicalTrials.gov ID
- NCT05487859
- Acronym / sponsor ID
- UAB23143
- Conditions
- Kidney Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due to overall cost of the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Aug 2022 (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 purpose of this study is to determine the safety and tolerability of acarbose in combination of immunotherapy based standard of care therapy in advanced renal cell carcinoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Acarbose TabletsIpilimumab (1 mg/kg) IV q3wks + Nivolumab (3mg/kg) IV q3wks + Acarbose (upto 100 mg PO TID) followed by Nivolumab 480 mg IV q4 wks + Acarbose (upto 100 mg PO TID) OR Pembrolizumab 200 mg IV q3 wks or 400 mg IV q6 wks + Lenvatinib (up to 20 mg PO Daily) + Acarbose (upto 100 mg PO TID) [ Frontline/Refractory pts] OR Lenvatinib (upto 18 mg PO daily) + Everolimus (upto 5 mg PO Daily) + Acarbose (upto 100 mg PO TID) [ Refractory pts] OR Cabozantinib (upto 60 mg PO Daily) + Acarbose (upto 100 mg PO TID) [Refractory pts] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed diagnosis of clear cell or non-clear cell carcinoma of the kidney, except for medullary carcinoma, collecting duct carcinoma, lymphoma and sarcoma. Sarcomatoid features of any degree are allowed
- Must have locally advanced or unresectable metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease.
- Has measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist.
- Has received no prior systemic therapy for advanced RCC in the past 3 weeks.
- Has Karnofsky performance status (KPS) ≥ 60% as assessed within 10 days prior to randomization.
Key exclusion criteria (14 listed)
- 1. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization.
- 2. Has had major surgery within 4 weeks, received radiation therapy within 2 weeks prior to randomization, or has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to prior treatment.
- 3. Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to acarbose or investigators choice of standard of care therapy.
- 4. Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding physiologic corticosteroid dose or any other form of immunosuppressive therapy within 7 days prior to randomization, except in the case of central nervous system (CNS) metastases.
- 5. Has an active autoimmune disease requiring systemic treatment with in the past 2 years OR a documented history of clinically severe autoimmune disease. Note: Participants with vitiligo, Sjøgren's syndrome, Type 1 diabetes, resolved childhood asthma/atopy, hypothyroidism or adrenal or pituitary insufficiency who are stable on hormone replacement, are not excluded.
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 |
|---|---|---|
| Acarbose TabletsAcarbose Tablets PO ranging from 25 mg initially to 100 mg as tolerated | Drug | Arm 1 |
Primary outcome
To assess the safety profile of acarbose in addition to standard of care (SOC) treatment in RCC
Time frame: 2 years
adverse events will be defined and assessed using the National Cancer Institute's Common Terminology Criteria (CTCAE) v5.0
To assess the effect of acarbose on the gut microbiome in patients receiving as standard of care therapy.
Time frame: 2 years
Fecal microbiota populations will be characterized prior, during and after treatment with acarbose.
2 secondary outcomes
To assess the efficacy of Acarbose in combination with SOC treatment in RCC
Time frame: 2 years
To assess the efficacy of Acarbose in combination with SOC treatment in RCC
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acarbose Tablets in people with Kidney Cancer, run by University of Alabama at Birmingham.
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 12 inclusion and 14 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: withdrawn, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety profile of acarbose in addition to standard of care (SOC) treatment in RCC (time frame: 2 years). The study lists 2 primary outcomes in all. 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 17 Feb 2026.