This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
CLINICAL STUDIES
- The safety and efficacy of INVOKANAwas not evaluated in patients with a history of kidney transplant.
- In the CREDENCE trial1 (N=4,401), a randomized, double-blind, parallel group, placebo-controlled study assessing the effects of INVOKANA (100mg) compared to placebo (PBO) in albuminuric diabetic nephropathy, patients with renal disease requiring treatment with immunosuppressive therapy and patients with a history of chronic dialysis or renal transplant were excluded.2
- The CANVAS Program3 (N=10,142), a pre-specified integrated analysis of the phase 3 trial CANVAS4 and the phase 4 trial CANVAS-R5, assessed the cardiovascular safety and efficacy of INVOKANA compared to placebo and excluded patients with renal disease requiring treatment with immunosuppressive therapy and patients with a history of dialysis or renal transplant.6
- Patients with renal disease requiring treatment with immunosuppressive therapy and patients with a history of dialysis or renal transplant were excluded from INVOKANAphase 3 studies.7,8
Case Series
Case studies reporting the use of INVOKANA in kidney transplant patients are listed in the REFERENCES section.9,10
LITERATURE SEARCH
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, DERWENT® (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 30 April 2025.
1 | Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(23):2295-2306. |
2 | Perkovic V, Jardine MJ, B N, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy: protocol and statistical analysis plan. N Engl J Med. 2019;380(24):2295-2306. |
3 | Neal B, Perkovic V, Matthews DR. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377(21):2099. |
4 | Neal B, Perkovic V, de Zeeuw D, et al. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)—a randomized placebo-controlled trial. Am Heart J. 2013;166(2):217-223.e11. |
5 | Neal B, Perkovic V, Matthews DR, et al. Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R): a randomized, placebo-controlled trial. Diabetes Obes Metab. 2017;19(3):387-393. |
6 | Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes [Protocol]. N Engl J Med. 2017;377(7):644-657. |
7 | Food and Drug Administration (FDA). Invokana (canagliflozin) Tablets - Medical Review(s). Center for Drug Evaluation and Research (CDER); 2024. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204042Orig1s000TOC.cfm Accessed April 30, 2025. |
8 | Neal B, Perkovic V, de Zeeuw D, et al. Supplement to: Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)-a randomized placebo-controlled trial. Am Heart J. 2013;166(2):217-223.e11. |
9 | Rajasekeran H, Kim SJ, Cardella CJ, et al. Use of canagliflozin in kidney transplant recipients for the treatment of type 2 diabetes: a case series. Diabetes Care. 2017;40(7):e75-e76. |
10 | Shah M, Virani Z, Rajput P, et al. Efficacy and safety of canagliflozin in kidney transplant patients. Indian J Nephrol. 2019;29(4):278-281. |