Abstract | BACKGROUND: METHODS: Two Phase 3, open-label, sponsor-blind, active-controlled trials enrolled adults with anaemia of CKD who recently initiated dialysis and had limited ESA exposure (incident DD-CKD trial) or were receiving maintenance dialysis with ESA treatment (prevalent DD-CKD trial). Study periods include correction/conversion (Weeks 0-23), maintenance (Weeks 24-52), long-term treatment (Weeks 53 to end of treatment) and safety follow-up. The primary safety endpoint is the time to the first major adverse cardiovascular event and the primary efficacy endpoint is the change in haemoglobin (baseline to Weeks 24-36). RESULTS: A total of 369 and 3554 patients were randomized in the incident DD-CKD and prevalent DD-CKD trials, respectively. Demographics and baseline characteristics were similar among patients in both trials and comparable to those typically observed in DD-CKD. CONCLUSIONS: The two INNO2VATE trials will provide important information on the safety and efficacy of a novel approach for anaemia management in a diverse DD-CKD population. Demographics and baseline characteristics of enrolled patients suggest that study results will be representative for a large proportion of the DD-CKD population.
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Authors | Kai-Uwe Eckardt, Rajiv Agarwal, Youssef Mk Farag, Alan G Jardine, Zeeshan Khawaja, Mark J Koury, Wenli Luo, Kunihiro Matsushita, Peter A McCullough, Patrick Parfrey, Geoffrey Ross, Mark J Sarnak, Dennis Vargo, Wolfgang C Winkelmayer, Glenn M Chertow |
Journal | Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
(Nephrol Dial Transplant)
Vol. 36
Issue 11
Pg. 2039-2048
(11 09 2021)
ISSN: 1460-2385 [Electronic] England |
PMID | 33188693
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © The Author(s) 2020. Published by Oxford University Press on behalf of ERA-EDTA. |
Chemical References |
- Hematinics
- Hemoglobins
- Picolinic Acids
- vadadustat
- Erythropoietin
- Glycine
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Topics |
- Adult
- Anemia
(drug therapy, etiology)
- Erythropoietin
- Glycine
(analogs & derivatives, therapeutic use)
- Hematinics
(therapeutic use)
- Hemoglobins
(analysis)
- Humans
- Picolinic Acids
(therapeutic use)
- Renal Dialysis
- Renal Insufficiency, Chronic
(complications, therapy)
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