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) was conducted on 11 May 2023.