DialysisPhase 4CANIDIAPNCT07527390
CANagliflozin In DIALysis Patients
A Phase 4 study testing Invokana 300 mg and 100 mg tablet in people with Dialysis and Chronic Kidney Disease (Stages 4 and 5), run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: Sodium glucose co-transporter 2 (SGLT2) inhibitors are a relatively new class of drugs originally developed for the treatment of diabetes. Cardiovascular outcome trials with these drugs showed also beneficial effects of these agents on heart failure, cardiovascular disease and kidney outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis, Chronic Kidney Disease (Stages 4 and 5)
- What is being tested?
- Invokana 300 mg and 100 mg tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2026to 30 Jan 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodialysis for more than 3 months (5 also with residual diuresis)
- Age ≥18 years of age
- Willing to sign informed consent
Who cannot join
- Mentally incapacitated subjects (i.e. not able to sign informed consent)
- Subjects who participated in a trial with exposure to radiation before, are only allowed to participate if the total cumulative radiation burden in their life does not exceed 1 mSv per year, counting from the age of 18 years.
- Pregnant women and women of child-bearing potential who are not using reliable contraception
- Subjects on diuretics are allowed to participate but the dose should be stable for at least 4 weeks prior to screening
- Subjects already on a SGLT2 inhibitor are allowed to participate, but the drug should be inter-rupted 1 week prior to the first study day till the end of the second study day (as the half-life is 10-13 hours a wash-out of the study drug of at least 7-days should be considered)
- History of hypersensitivity to canagliflozin or another SGLT2 inhibitor
Show all 18Show fewer
- Severe claustrophobia
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
- Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
- Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
- Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months
- Pancreatic injury or pancreatitis within the last six months
- Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- Use of rifampicin and cholestryramine
- Established peripheral arterial disease
- Active cardiovascular disease: myocardial infarction, angina pectoris, percutaneous translu-minal coronary angioplasty, coronary artery bypass grafting, stroke, or heart failure (NYHA I-IV) admission < 3 months before inclusion
- People using digoxin and/or lithium
- Patients with an active malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 GZ
Hiddo Lambers Heerspink, Prof., +31 50 361 4071, h.j.lambers.heerspink@umcg.nl
About this study
Rationale:
Sodium glucose co-transporter 2 (SGLT2) inhibitors are a relatively new class of drugs originally developed for the treatment of diabetes. Cardiovascular outcome trials with these drugs showed also beneficial effects of these agents on heart failure, cardiovascular disease and kidney outcomes. Secondary analyses from these trials demonstrated that these benefits were consistent in patients with or without type 2 diabetes and with or without chronic kidney disease (CKD) with a lower eGFR threshold of 20 mL/min/1.73m2. However, it is not yet clear if these drugs can also be used in patients with severe kidney disease who require dialysis. This is in part explained because SGLT2 inhibitors bind to a transporter which is located in the luminal side of proximal tubes in the kidney. If kidney function is low, and these patients have no or limited filtering capacity, it is possible that the efficacy of these drugs decrease. Notwithstanding, several animal experiments and preliminary clinical data have suggested that these drugs do have kidney and cardiac protective effects in case of severely decreased kidney function.
The investigators hypothesize that SGLT2 inhibitors are distributed to several tissues in the body on top of the kidney and therefore the investigators would like to investigate the specific tissue distribution of SGLT2 inhibitors in patients on dialysis with-and without residual diuresis.
Read the detailed description
Main objective:
The main objective of this exploratory study is to investigate specific tissue distribution of SGLT2 inhibitors in patients on dialysis with-and without residual diuresis and visualize this by the use of 18F- canagliflozin.
Secondary objective:
To investigate 18F- canagliflozin binding in specific regions of interest:
- The proximal tubule of the kidney
- Cardiac tissue
- Vascular tissue
- Brain tissue
To compare whether tissue distribution is different between dialysis patients who have and that do not have residual diuresis.
Study design:
This is an open-label exploratory study. The study will consist of a screening visit and 2 study days, separated by a one-week interval.
Study population:
The trial population will consists of 10 patients ≥18 years of age who are on dialysis for more than 3 months with or without residual diuresis and as exclusion criteria a total cumulative radiation burden above 1mSv per year (from the age of 18 years), a history of hypersensitivity to canagliflozin, any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications or peripheral/cardiovascular disease.
Interventions:
On both study days, a blood sample will be obtained for routine clinical care. A non-diagnostic CT scan will be performed to optimally position the individual participant for the PET scan. In all participants, two 60-minute PET scans will be obtained. On the first study day, following IV radiotracer administration, a baseline 60-minute PET scan will be taken to measure uptake and accumulation of 18F- canagliflozin. On the second study day (approximately 1 week after the first study day), following oral administration of 600 mg canagliflozin, a second IV radiotracer dose will be administered followed by a 60- minute PET scan (post-drug). Venous lines will be placed prior to the PET-scans to inject the dose and for venous sampling. In this study venous sampling was implemented as arterial sampling appeared to be burdensome for both personnel and participants.
Main study endpoint:
The main endpoint of the study is overall drug tissue disposition of SGLT2 in patients on dialysis quantified by images obtained by PET imaging.
Secondary study endpoint:
Receptor occupancy of SGLT2 in the regions of interest (proximal tubule of the kidney, cardiac tissue, vascular tissue, brain tissue) as quantified by images obtained by PET imaging.
Study visits:
Screening visit, study day 1, study day 2.
Sample size:
The sample size planned for this study is 10 participants, allocated n=5 to the residual diuresis group and n = 5 to the non-residual diuresis group. The sample size is based on prior experience of a variability and feasibility study with 18-F canagliflozin in a cohort of 9 patients with T2DM.
- Conditions
- Dialysis, Chronic Kidney Disease (Stages 4 and 5)
- Being tested
- Invokana 300 mg and 100 mg tablet
- Keywords
- SGLT2 inhibitors, PET imaging
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invokana 300 mg and 100 mg tabletDrug
A 600 mg dose of canagliflozin (two 300 mg tablets) will be administered orally by the participant
| Study group | Role | What they receive |
|---|---|---|
| Radiotracer 18F- canagliflozin | Experimental | On the first study day the radiotracer 18F- canagliflozin will be administered intravenously. On the second study day, following oral administration of 600 mg of canagliflozin, a second radiotracer dose of 18F- canagliflozin will be administered intravenously. Receives: Drug: Invokana 300 mg and 100 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall drug tissue disposition of SGLT2 in patients on dialysis.
The main outcome of the study is overall drug tissue disposition of SGLT2 in patients on dialysis. quantified by images obtained by PET imaging.
Measured: From enrollment to the second study day, seperated by approximately one-week intervals.
Secondary outcomes (1)
Receptor occupancy of SGLT2 in the regions of interest.
Receptor occupancy of SGLT2 in the regions of interest (proximal tubule of the kidney, cardiac tissue, vascular tissue, brain tissue) as quantified by images obtained by PET imaging.
Measured: From enrollment to the second study day, seperated by approximately one-week intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DialysisStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527390
- Sponsor's protocol ID
- 20725
- Other IDs
- 2025-522742-46-00, 2025
- Acronym
- CANIDIAP
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.
PubMed 30990260Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
PubMed 32970396The EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Wanner C, Green JB, Hauske SJ, Emberson JR, Preiss D, Judge P, Mayne KJ, Ng SYA, Sammons E, Zhu D, Hill M, Stevens W, Wallendszus K, Brenner S, Cheung AK, Liu ZH, Li J, Hooi LS, Liu W, Kadowaki T, Nangaku M, Levin A, Cherney D, Maggioni AP, Pontremoli R, Deo R, Goto S, Rossello X, Tuttle KR, Steubl D, Petrini M, Massey D, Eilbracht J, Brueckmann M, Landray MJ, Baigent C, Haynes R. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023 Jan 12;388(2):117-127. doi: 10.1056/NEJMoa2204233. Epub 2022 Nov 4.
PubMed 36331190Juni RP, Al-Shama R, Kuster DWD, van der Velden J, Hamer HM, Vervloet MG, Eringa EC, Koolwijk P, van Hinsbergh VWM. Empagliflozin restores chronic kidney disease-induced impairment of endothelial regulation of cardiomyocyte relaxation and contraction. Kidney Int. 2021 May;99(5):1088-1101. doi: 10.1016/j.kint.2020.12.013. Epub 2020 Dec 23.
PubMed 33359500Uthman L, Homayr A, Juni RP, Spin EL, Kerindongo R, Boomsma M, Hollmann MW, Preckel B, Koolwijk P, van Hinsbergh VWM, Zuurbier CJ, Albrecht M, Weber NC. Empagliflozin and Dapagliflozin Reduce ROS Generation and Restore NO Bioavailability in Tumor Necrosis Factor alpha-Stimulated Human Coronary Arterial Endothelial Cells. Cell Physiol Biochem. 2019;53(5):865-886. doi: 10.33594/000000178.
PubMed 31724838Billing AM, Kim YC, Gullaksen S, Schrage B, Raabe J, Hutzfeldt A, Demir F, Kovalenko E, Lasse M, Dugourd A, Fallegger R, Klampe B, Jaegers J, Li Q, Kravtsova O, Crespo-Masip M, Palermo A, Fenton RA, Hoxha E, Blankenberg S, Kirchhof P, Huber TB, Laugesen E, Zeller T, Chrysopoulou M, Saez-Rodriguez J, Magnussen C, Eschenhagen T, Staruschenko A, Siuzdak G, Poulsen PL, Schwab C, Cuello F, Vallon V, Rinschen MM. Metabolic Communication by SGLT2 Inhibition. Circulation. 2024 Mar 12;149(11):860-884. doi: 10.1161/CIRCULATIONAHA.123.065517. Epub 2023 Dec 28.
PubMed 38152989Bakker WM, Heerspink HJL, Berger SP, Wanner C, Badve SV, Arnott C, Abrahams AC, van den Born JC, van Faassen TC, Gaillard CAJM, Gelens MACJ, Gorris JL, Hemmelder MH, Jakulj L, van Kruijsdijk RCM, Kuypers DRJ, van der Meer P, van der Net JB, Nijmeijer HH, Vervloet MG, de Vries APJ, Walsh M, Wang AY, Gansevoort RT; Renal Lifecycle Trial Investigators. Rationale and design of the Renal Lifecycle trial assessing the effect of dapagliflozin on cardiorenal outcomes in severe chronic kidney disease. Nephrol Dial Transplant. 2025 Aug 29;40(9):1746-1755. doi: 10.1093/ndt/gfaf046.
PubMed 40053493van der Hoek S, Willemsen ATM, Visser T, Heeres A, Mulder DJ, Bokkers RPH, Slart RHJA, Elsinga PH, Heerspink HJL, Stevens J. Feasibility Study to Assess Canagliflozin Distribution and Sodium-Glucose Co-Transporter 2 Occupancy Using [18 F]Canagliflozin in Patients with Type 2 Diabetes. Clin Pharmacol Ther. 2023 Jun;113(6):1295-1303. doi: 10.1002/cpt.2886. Epub 2023 Mar 26.
PubMed 36897753
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CANagliflozin In DIALysis Patients
- ClinicalTrials.gov ID
- NCT07527390
- Acronym / sponsor ID
- CANIDIAP / 20725
- Conditions
- Dialysis, Chronic Kidney Disease (Stages 4 and 5)
- Keywords
- SGLT2 inhibitors, PET imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 14 Apr 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.
Rationale:
Sodium glucose co-transporter 2 (SGLT2) inhibitors are a relatively new class of drugs originally developed for the treatment of diabetes. Cardiovascular outcome trials with these drugs showed also beneficial effects of these agents on heart failure, cardiovascular disease and kidney outcomes. Secondary analyses from these trials demonstrated that these benefits were consistent in patients with or without type 2 diabetes and with or without chronic kidney disease (CKD) with a lower eGFR threshold of 20 mL/min/1.73m2. However, it is not yet clear if these drugs can also be used in patients with severe kidney disease who require dialysis. This is in part explained because SGLT2 inhibitors bind to a transporter which is located in the luminal side of proximal tubes in the kidney. If kidney function is low, and these patients have no or limited filtering capacity, it is possible that the efficacy of these drugs decrease. Notwithstanding, several animal experiments and preliminary clinical data have suggested that these drugs do have kidney and cardiac protective effects in case of severely decreased kidney function.
The investigators hypothesize that SGLT2 inhibitors are distributed to several tissues in the body on top of the kidney and therefore the investigators would like to investigate the specific tissue distribution of SGLT2 inhibitors in patients on dialysis with-and without residual diuresis.
Detailed description
Main objective:
The main objective of this exploratory study is to investigate specific tissue distribution of SGLT2 inhibitors in patients on dialysis with-and without residual diuresis and visualize this by the use of 18F- canagliflozin.
Secondary objective:
To investigate 18F- canagliflozin binding in specific regions of interest:
- The proximal tubule of the kidney
- Cardiac tissue
- Vascular tissue
- Brain tissue
To compare whether tissue distribution is different between dialysis patients who have and that do not have residual diuresis.
Study design:
This is an open-label exploratory study. The study will consist of a screening visit and 2 study days, separated by a one-week interval.
Study population:
The trial population will consists of 10 patients ≥18 years of age who are on dialysis for more than 3 months with or without residual diuresis and as exclusion criteria a total cumulative radiation burden above 1mSv per year (from the age of 18 years), a history of hypersensitivity to canagliflozin, any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications or peripheral/cardiovascular disease.
Interventions:
On both study days, a blood sample will be obtained for routine clinical care. A non-diagnostic CT scan will be performed to optimally position the individual participant for the PET scan. In all participants, two 60-minute PET scans will be obtained. On the first study day, following IV radiotracer administration, a baseline 60-minute PET scan will be taken to measure uptake and accumulation of 18F- canagliflozin. On the second study day (approximately 1 week after the first study day), following oral administration of 600 mg canagliflozin, a second IV radiotracer dose will be administered followed by a 60- minute PET scan (post-drug). Venous lines will be placed prior to the PET-scans to inject the dose and for venous sampling. In this study venous sampling was implemented as arterial sampling appeared to be burdensome for both personnel and participants.
Main study endpoint:
The main endpoint of the study is overall drug tissue disposition of SGLT2 in patients on dialysis quantified by images obtained by PET imaging.
Secondary study endpoint:
Receptor occupancy of SGLT2 in the regions of interest (proximal tubule of the kidney, cardiac tissue, vascular tissue, brain tissue) as quantified by images obtained by PET imaging.
Study visits:
Screening visit, study day 1, study day 2.
Sample size:
The sample size planned for this study is 10 participants, allocated n=5 to the residual diuresis group and n = 5 to the non-residual diuresis group. The sample size is based on prior experience of a variability and feasibility study with 18-F canagliflozin in a cohort of 9 patients with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotracer 18F- canagliflozin | Experimental | Drug: Invokana 300 mg and 100 mg tabletOn the first study day the radiotracer 18F- canagliflozin will be administered intravenously. On the second study day, following oral administration of 600 mg of canagliflozin, a second radiotracer dose of 18F- canagliflozin will be administered intravenously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hemodialysis for more than 3 months (5 also with residual diuresis)
- Age ≥18 years of age
- Willing to sign informed consent
Key exclusion criteria (18 listed)
- Mentally incapacitated subjects (i.e. not able to sign informed consent)
- Subjects who participated in a trial with exposure to radiation before, are only allowed to participate if the total cumulative radiation burden in their life does not exceed 1 mSv per year, counting from the age of 18 years.
- Pregnant women and women of child-bearing potential who are not using reliable contraception
- Subjects on diuretics are allowed to participate but the dose should be stable for at least 4 weeks prior to screening
- Subjects already on a SGLT2 inhibitor are allowed to participate, but the drug should be inter-rupted 1 week prior to the first study day till the end of the second study day (as the half-life is 10-13 hours a wash-out of the study drug of at least 7-days should be considered)
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 |
|---|---|---|
| Invokana 300 mg and 100 mg tabletA 600 mg dose of canagliflozin (two 300 mg tablets) will be administered orally by the participant | Drug | Radiotracer 18F- canagliflozin |
Primary outcome
Overall drug tissue disposition of SGLT2 in patients on dialysis.
Time frame: From enrollment to the second study day, seperated by approximately one-week intervals.
The main outcome of the study is overall drug tissue disposition of SGLT2 in patients on dialysis. quantified by images obtained by PET imaging.
1 secondary outcome
Receptor occupancy of SGLT2 in the regions of interest.
Time frame: From enrollment to the second study day, seperated by approximately one-week intervals.
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 6 May 2026.
- Background: PubMed 30990260Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.
- Background: PubMed 32970396Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
- Background: PubMed 36331190The EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Wanner C, Green JB, Hauske SJ, Emberson JR, Preiss D, Judge P, Mayne KJ, Ng SYA, Sammons E, Zhu D, Hill M, Stevens W, Wallendszus K, Brenner S, Cheung AK, Liu ZH, Li J, Hooi LS, Liu W, Kadowaki T, Nangaku M, Levin A, Cherney D, Maggioni AP, Pontremoli R, Deo R, Goto S, Rossello X, Tuttle KR, Steubl D, Petrini M, Massey D, Eilbracht J, Brueckmann M, Landray MJ, Baigent C, Haynes R. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023 Jan 12;388(2):117-127. doi: 10.1056/NEJMoa2204233. Epub 2022 Nov 4.
- Background: PubMed 33359500Juni RP, Al-Shama R, Kuster DWD, van der Velden J, Hamer HM, Vervloet MG, Eringa EC, Koolwijk P, van Hinsbergh VWM. Empagliflozin restores chronic kidney disease-induced impairment of endothelial regulation of cardiomyocyte relaxation and contraction. Kidney Int. 2021 May;99(5):1088-1101. doi: 10.1016/j.kint.2020.12.013. Epub 2020 Dec 23.
- Background: PubMed 31724838Uthman L, Homayr A, Juni RP, Spin EL, Kerindongo R, Boomsma M, Hollmann MW, Preckel B, Koolwijk P, van Hinsbergh VWM, Zuurbier CJ, Albrecht M, Weber NC. Empagliflozin and Dapagliflozin Reduce ROS Generation and Restore NO Bioavailability in Tumor Necrosis Factor alpha-Stimulated Human Coronary Arterial Endothelial Cells. Cell Physiol Biochem. 2019;53(5):865-886. doi: 10.33594/000000178.
- Background: PubMed 38152989Billing AM, Kim YC, Gullaksen S, Schrage B, Raabe J, Hutzfeldt A, Demir F, Kovalenko E, Lasse M, Dugourd A, Fallegger R, Klampe B, Jaegers J, Li Q, Kravtsova O, Crespo-Masip M, Palermo A, Fenton RA, Hoxha E, Blankenberg S, Kirchhof P, Huber TB, Laugesen E, Zeller T, Chrysopoulou M, Saez-Rodriguez J, Magnussen C, Eschenhagen T, Staruschenko A, Siuzdak G, Poulsen PL, Schwab C, Cuello F, Vallon V, Rinschen MM. Metabolic Communication by SGLT2 Inhibition. Circulation. 2024 Mar 12;149(11):860-884. doi: 10.1161/CIRCULATIONAHA.123.065517. Epub 2023 Dec 28.
- Background: PubMed 40053493Bakker WM, Heerspink HJL, Berger SP, Wanner C, Badve SV, Arnott C, Abrahams AC, van den Born JC, van Faassen TC, Gaillard CAJM, Gelens MACJ, Gorris JL, Hemmelder MH, Jakulj L, van Kruijsdijk RCM, Kuypers DRJ, van der Meer P, van der Net JB, Nijmeijer HH, Vervloet MG, de Vries APJ, Walsh M, Wang AY, Gansevoort RT; Renal Lifecycle Trial Investigators. Rationale and design of the Renal Lifecycle trial assessing the effect of dapagliflozin on cardiorenal outcomes in severe chronic kidney disease. Nephrol Dial Transplant. 2025 Aug 29;40(9):1746-1755. doi: 10.1093/ndt/gfaf046.
- Background: PubMed 36897753van der Hoek S, Willemsen ATM, Visser T, Heeres A, Mulder DJ, Bokkers RPH, Slart RHJA, Elsinga PH, Heerspink HJL, Stevens J. Feasibility Study to Assess Canagliflozin Distribution and Sodium-Glucose Co-Transporter 2 Occupancy Using [18 F]Canagliflozin in Patients with Type 2 Diabetes. Clin Pharmacol Ther. 2023 Jun;113(6):1295-1303. doi: 10.1002/cpt.2886. Epub 2023 Mar 26.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Invokana 300 mg and 100 mg tablet in people with Dialysis and Chronic Kidney Disease (Stages 4 and 5), run by University Medical Center Groningen at 1 site in Netherlands.
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 3 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: opening soon, as of the sponsor's last update on 6 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 Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Hiddo Lambers Heerspink, Prof. (+31 50 361 4071, h.j.lambers.heerspink@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall drug tissue disposition of SGLT2 in patients on dialysis. (time frame: From enrollment to the second study day, seperated by approximately one-week intervals.). 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 NCT07527390, which also lists 8 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 6 May 2026.