Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)Phase 2EMPA-CKDNCT07175051
Targeting the Pathophysiology of Sickle Cell-Related Kidney Disease Using the SGLT2 Inhibitors, Empagliflozin
A Phase 2 study testing Empagliflozin (oral) in people with Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0) and Albuminuria, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Sickle cell anemia (SCA) is an inherited red blood disorder. The kidneys are among the most commonly affected organ systems in SCA. The Food and Drug Administration (FDA) has approved empagliflozin as a treatment to reduce the decline of kidney function in those with kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0), Albuminuria
- What is being tested?
- Empagliflozin (oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to Oct 2030
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Documentation of SCA genotype (HbSS or HbSβ0-thalassemia)
- Albuminuria defined by a UACR of 100 - 2,000 mg/g creatinine at the screening
- Hemoglobin (Hb) ≥ 5.5 g/dL during screening
- For participants taking Endari, the dose of Endari must be stable for at least one month prior to signing the ICF and with no anticipated need for dose adjustments during the study
- For participants on crizanlizumab or chronic red blood cell transfusions, the therapy must have started at least 3 months prior to consent
- For participants taking an angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB), the dose must be stable for at least 3 months prior to signing the ICF and with no anticipated need for dose adjustments during the study, in the opinion of the Investigator
Show all 9Show fewer
- Participants must demonstrate regular compliance with clinic visits and outpatient management
- Participants, if female and of childbearing potential, will use highly effective methods of contraception from study start to 30 days after the last dose of the study drug
- Participant has provided documented informed consent or assent
Who cannot join
- Concurrent diagnosis of diabetes mellitus
- Female who is breast feeding, pregnant, or unwilling to use birth control as described in the protocol
- Prior hypersensitivity or intolerance to a sodium-glucose cotransporter-2 inhibitor (SGLT2i)
- Active or open leg ankle ulcer
- Chronic urinary tract infection
- Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days prior to signing consent
Show all 18Show fewer
- Hepatic dysfunction characterized by alanine aminotransferase (ALT) >5× ULN
- Participants with acute bacterial infection requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed
- Participants with known active hepatitis A, B, or C or who are known to be human immunodeficiency virus (HIV) positive
- Moderate to severe CKD (defined by an eGFR < 30 mL/min/1.73m2, on chronic dialysis, or having received a kidney transplantation)
- History of malignancy within the past 2 years prior to treatment Day 1 requiring chemotherapy and/or radiation (with the exception of local therapy for non-melanoma skin malignancy)
- History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to the following:
- Unstable angina pectoris or myocardial infarction or elective coronary intervention
- Uncontrolled clinically significant arrhythmias
- Any condition affecting drug absorption, such as major surgery involving the stomach (e.g. bariatric surgery) or small intestine (prior cholecystectomy is acceptable)
- Participated in another clinical trial of an investigational agent (or medical device) within 30 days or 5 half-lives of agent, whichever is longer, or is currently participating in another trial of an investigational agent or medical device)
- Medical, psychological, or behavioral conditions, which, in the opinion of the Investigator, may preclude safe participation, confound study interpretation, interfere with compliance, or preclude informed consent
- Contraindication to MRI (certain pacemakers, electronic implants, shrapnel in the eyes, or certain intracranial aneurysm clips)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anand Srivastave, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Illinois Chicago, Sickle Cell Center
Chicago, Illinois, 60302
Santosh L Saraf, MD, 312-996-5680, ssaraf@uic.edu
Anand Srivastava, MD
About this study
Sickle cell anemia (SCA) is an inherited red blood disorder. The kidneys are among the most commonly affected organ systems in SCA. The Food and Drug Administration (FDA) has approved empagliflozin as a treatment to reduce the decline of kidney function in those with kidney disease. The proposed research study aims to determine whether empagliflozin can prevent the progression of kidney dysfunction in patients with sickle cell anemia (SCA) who are at high risk of developing advanced chronic kidney disease (CKD).
- Being tested
- Empagliflozin (oral)
- Keywords
- Empa-CKD, Sickle Cell-Related Kidney Disease
- Medical subject headings
- Anemia, Sickle Cell, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin (oral)Drug
10 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Empagliflozin Receives: Drug: Empagliflozin (oral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of empagliflozin - urine biomarker: Adenosine
Adenosine (umol/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Measured: From enrollment to the end of treatment at 48 weeks
Efficacy of empagliflozin - urine biomarker: Nephrin
Nephrin (ng/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Measured: From enrollment to the end of treatment at 48 weeks
Efficacy of empagliflozin - urine biomarker: Kidney injury molecule-1
Kidney injury molecule-1 (ng/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Measured: From enrollment to the end of treatment at 48 weeks
Efficacy of empagliflozin R2* Cortical Oxygenation on kidney fMRI
fMRI-derived R2* average values from Visit 1 compared to the values from Visit 6.
Measured: From enrollment to the end of treatment at 48 weeks
Secondary outcomes (7)
Effects of empagliflozin on UACR
Change in UACR (mg/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6
Measured: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on 24-hour urine protein
24-hour urine protein (g/24 hours) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Measured: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on measures of eGFR
eGFR calculated by race-free serum creatinine and cystatin C-based equations (mL/min/1.73m2), average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6
Measured: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: suPAR
suPAR pg/mL average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Measured: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: Et-1
ET-1 pg/mL average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Measured: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: VCAM-1
VCAM-1 ng/mL average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Measured: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: sFLTI-1
sFLTI-1 ng/L average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Measured: From enrollment to the end of treatment at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start8 Apr 2026
- Primary completionOct 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (94)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)Studies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santosh L Saraf, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175051
- Sponsor's protocol ID
- 2025-0637
- Acronym
- EMPA-CKD
- Status last verified
- May 2026
- First submitted
- 21 Aug 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Srivastava A, Cai X, Lee J, Li W, Larive B, Kendrick C, Gassman JJ, Middleton JP, Carr J, Raphael KL, Cheung AK, Raj DS, Chonchol MB, Fried LF, Block GA, Sprague SM, Wolf M, Ix JH, Prasad PV, Isakova T. Kidney Functional Magnetic Resonance Imaging and Change in eGFR in Individuals with CKD. Clin J Am Soc Nephrol. 2020 Jun 8;15(6):776-783. doi: 10.2215/CJN.13201019. Epub 2020 Apr 28.
PubMed 32345747Prasad PV, Li LP, Thacker JM, Li W, Hack B, Kohn O, Sprague SM. Cortical Perfusion and Tubular Function as Evaluated by Magnetic Resonance Imaging Correlates with Annual Loss in Renal Function in Moderate Chronic Kidney Disease. Am J Nephrol. 2019;49(2):114-124. doi: 10.1159/000496161. Epub 2019 Jan 22.
PubMed 30669143Prasad PV, Li W, Raj DS, Carr J, Carr M, Thacker J, Li LP, Wang C, Sprague SM, Ix JH, Chonchol M, Block G, Cheung AK, Raphael K, Gassman J, Wolf M, Fried LF, Isakova T; CKD Optimal Management with BInders and NicotinamidE (COMBINE) study group. Multicenter Study Evaluating Intrarenal Oxygenation and Fibrosis Using Magnetic Resonance Imaging in Individuals With Advanced CKD. Kidney Int Rep. 2018 Jul 7;3(6):1467-1472. doi: 10.1016/j.ekir.2018.07.006. eCollection 2018 Nov. No abstract available.
PubMed 30450473Wang J, Silaghi P, Guo C, Harro D, Eitzman DT. Inhibition of sodium-glucose cotransporter-2 improves anaemia in mice and humans with sickle cell disease, and reduces infarct size in a murine stroke model. J Cell Mol Med. 2024 Sep;28(17):e70091. doi: 10.1111/jcmm.70091.
PubMed 39267208Tian Q, Guo K, Deng J, Zhong Y, Yang L. Effects of SGLT2 inhibitors on haematocrit and haemoglobin levels and the associated cardiorenal benefits in T2DM patients: A meta-analysis. J Cell Mol Med. 2022 Jan;26(2):540-547. doi: 10.1111/jcmm.17115. Epub 2021 Dec 8.
PubMed 34878225von Eynatten M, Baumann M, Heemann U, Zdunek D, Hess G, Nawroth PP, Bierhaus A, Humpert PM. Urinary L-FABP and anaemia: distinct roles of urinary markers in type 2 diabetes. Eur J Clin Invest. 2010 Feb;40(2):95-102. doi: 10.1111/j.1365-2362.2009.02220.x. Epub 2009 Nov 11.
PubMed 19912308Johannes T, Mik EG, Nohe B, Unertl KE, Ince C. Acute decrease in renal microvascular PO2 during acute normovolemic hemodilution. Am J Physiol Renal Physiol. 2007 Feb;292(2):F796-803. doi: 10.1152/ajprenal.00206.2006. Epub 2006 Oct 31.
PubMed 17077389Grune T, Sommerburg O, Siems WG. Oxidative stress in anemia. Clin Nephrol. 2000 Feb;53(1 Suppl):S18-22.
PubMed 10746801Asnani MR, Lynch O, Reid ME. Determining glomerular filtration rate in homozygous sickle cell disease: utility of serum creatinine based estimating equations. PLoS One. 2013 Jul 19;8(7):e69922. doi: 10.1371/journal.pone.0069922. Print 2013.
PubMed 23894560Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.
PubMed 19414839Thrower A, Ciccone EJ, Maitra P, Derebail VK, Cai J, Ataga KI. Effect of renin-angiotensin-aldosterone system blocking agents on progression of glomerulopathy in sickle cell disease. Br J Haematol. 2019 Jan;184(2):246-252. doi: 10.1111/bjh.15651. Epub 2018 Nov 21.
PubMed 30460977Wright JT Jr, Bakris G, Greene T, Agodoa LY, Appel LJ, Charleston J, Cheek D, Douglas-Baltimore JG, Gassman J, Glassock R, Hebert L, Jamerson K, Lewis J, Phillips RA, Toto RD, Middleton JP, Rostand SG; African American Study of Kidney Disease and Hypertension Study Group. Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial. JAMA. 2002 Nov 20;288(19):2421-31. doi: 10.1001/jama.288.19.2421.
PubMed 12435255Heerspink HJ, Kropelin TF, Hoekman J, de Zeeuw D; Reducing Albuminuria as Surrogate Endpoint (REASSURE) Consortium. Drug-Induced Reduction in Albuminuria Is Associated with Subsequent Renoprotection: A Meta-Analysis. J Am Soc Nephrol. 2015 Aug;26(8):2055-64. doi: 10.1681/ASN.2014070688. Epub 2014 Nov 24.
PubMed 25421558Abo-Zenah H, Moharram M, El Nahas AM. Cardiorenal risk prevalence in sickle cell hemoglobinopathy. Nephron Clin Pract. 2009;112(2):c98-c106. doi: 10.1159/000213897. Epub 2009 Apr 23.
PubMed 19390209Mayr A, Pfeifer F. The characterization of the nv-gvpACNOFGH gene cluster involved in gas vesicle formation in Natronobacterium vacuolatum. Arch Microbiol. 1997 Jul;168(1):24-32. doi: 10.1007/s002030050465.
PubMed 9211710
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Pathophysiology of Sickle Cell-Related Kidney Disease Using the SGLT2 Inhibitors, Empagliflozin
- ClinicalTrials.gov ID
- NCT07175051
- Acronym / sponsor ID
- EMPA-CKD / 2025-0637
- Keywords
- Empa-CKD, Sickle Cell-Related Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 16 Sep 2025 (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.
Sickle cell anemia (SCA) is an inherited red blood disorder. The kidneys are among the most commonly affected organ systems in SCA. The Food and Drug Administration (FDA) has approved empagliflozin as a treatment to reduce the decline of kidney function in those with kidney disease. The proposed research study aims to determine whether empagliflozin can prevent the progression of kidney dysfunction in patients with sickle cell anemia (SCA) who are at high risk of developing advanced chronic kidney disease (CKD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Empagliflozin (oral)Empagliflozin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Documentation of SCA genotype (HbSS or HbSβ0-thalassemia)
- Albuminuria defined by a UACR of 100 - 2,000 mg/g creatinine at the screening
- Hemoglobin (Hb) ≥ 5.5 g/dL during screening
- For participants taking Endari, the dose of Endari must be stable for at least one month prior to signing the ICF and with no anticipated need for dose adjustments during the study
- For participants on crizanlizumab or chronic red blood cell transfusions, the therapy must have started at least 3 months prior to consent
Key exclusion criteria (18 listed)
- Concurrent diagnosis of diabetes mellitus
- Female who is breast feeding, pregnant, or unwilling to use birth control as described in the protocol
- Prior hypersensitivity or intolerance to a sodium-glucose cotransporter-2 inhibitor (SGLT2i)
- Active or open leg ankle ulcer
- Chronic urinary tract infection
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 |
|---|---|---|
| Empagliflozin (oral)10 mg | Drug | Treatment |
Primary outcome
Efficacy of empagliflozin - urine biomarker: Adenosine
Time frame: From enrollment to the end of treatment at 48 weeks
Adenosine (umol/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Efficacy of empagliflozin - urine biomarker: Nephrin
Time frame: From enrollment to the end of treatment at 48 weeks
Nephrin (ng/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Efficacy of empagliflozin - urine biomarker: Kidney injury molecule-1
Time frame: From enrollment to the end of treatment at 48 weeks
Kidney injury molecule-1 (ng/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Efficacy of empagliflozin R2* Cortical Oxygenation on kidney fMRI
Time frame: From enrollment to the end of treatment at 48 weeks
fMRI-derived R2* average values from Visit 1 compared to the values from Visit 6.
7 secondary outcomes
Effects of empagliflozin on UACR
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on 24-hour urine protein
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on measures of eGFR
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: suPAR
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: Et-1
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: VCAM-1
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: sFLTI-1
Time frame: From enrollment to the end of treatment at 48 weeks
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 19 May 2026.
- Background: PubMed 32345747Srivastava A, Cai X, Lee J, Li W, Larive B, Kendrick C, Gassman JJ, Middleton JP, Carr J, Raphael KL, Cheung AK, Raj DS, Chonchol MB, Fried LF, Block GA, Sprague SM, Wolf M, Ix JH, Prasad PV, Isakova T. Kidney Functional Magnetic Resonance Imaging and Change in eGFR in Individuals with CKD. Clin J Am Soc Nephrol. 2020 Jun 8;15(6):776-783. doi: 10.2215/CJN.13201019. Epub 2020 Apr 28.
- Background: PubMed 30669143Prasad PV, Li LP, Thacker JM, Li W, Hack B, Kohn O, Sprague SM. Cortical Perfusion and Tubular Function as Evaluated by Magnetic Resonance Imaging Correlates with Annual Loss in Renal Function in Moderate Chronic Kidney Disease. Am J Nephrol. 2019;49(2):114-124. doi: 10.1159/000496161. Epub 2019 Jan 22.
- Background: PubMed 30450473Prasad PV, Li W, Raj DS, Carr J, Carr M, Thacker J, Li LP, Wang C, Sprague SM, Ix JH, Chonchol M, Block G, Cheung AK, Raphael K, Gassman J, Wolf M, Fried LF, Isakova T; CKD Optimal Management with BInders and NicotinamidE (COMBINE) study group. Multicenter Study Evaluating Intrarenal Oxygenation and Fibrosis Using Magnetic Resonance Imaging in Individuals With Advanced CKD. Kidney Int Rep. 2018 Jul 7;3(6):1467-1472. doi: 10.1016/j.ekir.2018.07.006. eCollection 2018 Nov. No abstract available.
- Background: PubMed 39267208Wang J, Silaghi P, Guo C, Harro D, Eitzman DT. Inhibition of sodium-glucose cotransporter-2 improves anaemia in mice and humans with sickle cell disease, and reduces infarct size in a murine stroke model. J Cell Mol Med. 2024 Sep;28(17):e70091. doi: 10.1111/jcmm.70091.
- Background: PubMed 34878225Tian Q, Guo K, Deng J, Zhong Y, Yang L. Effects of SGLT2 inhibitors on haematocrit and haemoglobin levels and the associated cardiorenal benefits in T2DM patients: A meta-analysis. J Cell Mol Med. 2022 Jan;26(2):540-547. doi: 10.1111/jcmm.17115. Epub 2021 Dec 8.
- Background: PubMed 19912308von Eynatten M, Baumann M, Heemann U, Zdunek D, Hess G, Nawroth PP, Bierhaus A, Humpert PM. Urinary L-FABP and anaemia: distinct roles of urinary markers in type 2 diabetes. Eur J Clin Invest. 2010 Feb;40(2):95-102. doi: 10.1111/j.1365-2362.2009.02220.x. Epub 2009 Nov 11.
- Background: PubMed 17077389Johannes T, Mik EG, Nohe B, Unertl KE, Ince C. Acute decrease in renal microvascular PO2 during acute normovolemic hemodilution. Am J Physiol Renal Physiol. 2007 Feb;292(2):F796-803. doi: 10.1152/ajprenal.00206.2006. Epub 2006 Oct 31.
- Background: PubMed 10746801Grune T, Sommerburg O, Siems WG. Oxidative stress in anemia. Clin Nephrol. 2000 Feb;53(1 Suppl):S18-22.
- Background: PubMed 23894560Asnani MR, Lynch O, Reid ME. Determining glomerular filtration rate in homozygous sickle cell disease: utility of serum creatinine based estimating equations. PLoS One. 2013 Jul 19;8(7):e69922. doi: 10.1371/journal.pone.0069922. Print 2013.
- Background: PubMed 19414839Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.
- Background: PubMed 30460977Thrower A, Ciccone EJ, Maitra P, Derebail VK, Cai J, Ataga KI. Effect of renin-angiotensin-aldosterone system blocking agents on progression of glomerulopathy in sickle cell disease. Br J Haematol. 2019 Jan;184(2):246-252. doi: 10.1111/bjh.15651. Epub 2018 Nov 21.
- Background: PubMed 12435255Wright JT Jr, Bakris G, Greene T, Agodoa LY, Appel LJ, Charleston J, Cheek D, Douglas-Baltimore JG, Gassman J, Glassock R, Hebert L, Jamerson K, Lewis J, Phillips RA, Toto RD, Middleton JP, Rostand SG; African American Study of Kidney Disease and Hypertension Study Group. Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial. JAMA. 2002 Nov 20;288(19):2421-31. doi: 10.1001/jama.288.19.2421.
- 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.
Anand Srivastave, MD contact
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 Empagliflozin (oral) in people with Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0) and Albuminuria, run by University of Illinois Chicago 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 18 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: looking for participants now, as of the sponsor's last update on 19 May 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. 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 Santosh L Saraf, MD (312-996-5680, ssaraf@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of empagliflozin - urine biomarker: Adenosine (time frame: From enrollment to the end of treatment at 48 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07175051, which also lists 94 linked publications.
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 19 May 2026.