NCT04013620 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Le Meur Y, Aulagnon F, Bertrand D, Heng AE, Lavaud S, Caillard S, Longuet H, Sberro-Soussan R, Doucet L, Grall A, Legendre C
Effect of an Early Switch to Belatacept Among Calcineurin Inhibitor-Intolerant Graft Recipients of Kidneys From Extended-Criteria
Vincenti F
Belatacept and Long-Term Outcomes in Kidney Transplantation. N Engl J Med. 2016 Jun 30;374(26):2600-1. doi: 10.1056/NEJMc1602859.

CNI Transient Replacement by Belatacept From 3 to 12 Months Post Transplantation in Patients With Early Graft Dysfunction

Clinical trial NCT04013620 - References