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Perioperative THR-184 and AKI after Cardiac Surgery
- Source :
- Journal of the American Society of Nephrology. 29:670-679
- Publication Year :
- 2017
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2017.
-
Abstract
- AKI after cardiac surgery is associated with mortality, prolonged hospital length of stay, use of dialysis, and subsequent CKD. We evaluated the effects of THR-184, a bone morphogenetic protein-7 agonist, in patients at high risk for AKI after cardiac surgery. We conducted a randomized, double-blind, placebo-controlled, multidose comparison of the safety and efficacy of perioperative THR-184 using a two-stage seamless adaptive design in 452 patients between 18 and 85 years of age who were scheduled for nonemergent cardiac surgery requiring cardiopulmonary bypass and had recognized risk factors for AKI. The primary efficacy end point was the proportion of patients who developed AKI according to Kidney Disease Improving Global Outcomes (KDIGO) criteria. The proportion of patients who developed AKI within 7 days of surgery was similar in THR-184 treatment groups and placebo groups (range, 74%–79%; P=0.43). Prespecified secondary end point analysis did not show significant differences in the severity of AKI stage (P=0.53) or the total duration of AKI (P=0.44). A composite of death, dialysis, or sustained impaired renal function by day 30 after surgery did not differ between groups (range, 11%–20%; P=0.46). Safety-related outcomes were similar across all treatment groups. In conclusion, compared with placebo, administration of perioperative THR-184 through a range of dose exposures failed to reduce the incidence, severity, or duration of AKI after cardiac surgery in high-risk patients.
- Subjects :
- Male
medicine.medical_specialty
Bone Morphogenetic Protein 7
medicine.medical_treatment
030204 cardiovascular system & hematology
urologic and male genital diseases
Placebo
Severity of Illness Index
law.invention
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Randomized controlled trial
Clinical Research
law
Cardiopulmonary bypass
medicine
Humans
Treatment Failure
030212 general & internal medicine
Cardiac Surgical Procedures
Perioperative Period
Dialysis
Aged
Aged, 80 and over
business.industry
Incidence (epidemiology)
General Medicine
Perioperative
Acute Kidney Injury
Middle Aged
medicine.disease
Cardiac surgery
Nephrology
Anesthesia
Female
business
Oligopeptides
Kidney disease
Subjects
Details
- ISSN :
- 15333450 and 10466673
- Volume :
- 29
- Database :
- OpenAIRE
- Journal :
- Journal of the American Society of Nephrology
- Accession number :
- edsair.doi.dedup.....329a9e3a7bb9adeba76b2253666342e9