NCT03657004 - 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)

Guethoff S, Stroeh K, Grinninger C, Koenig MA, Kleinert EC, Rieger A, Mayr T, von Ziegler F, Reichart B, Hagl C, Schramm R, Kaczmarek I, Meiser BM
De novo sirolimus with low-dose tacrolimus versus full-dose tacrolimus with mycophenolate mofetil after hea
Hellemons ME, Bakker SJ, Postmus D, Verschuuren EA, Erasmus ME, Navis G, van der Bij W
Incidence of impaired renal function after lung transplantation. J Heart Lung Transplant. 2012 Mar;31(3):238-43. doi: 10.1016/j.healun.2011.08.013. Epub 2011 Oct 5.

Impact of Switch of Immunosuppressive Regime on Changes in Renal Function and Transplant Rejection Rate in Patients With Lung Transplant

Clinical trial NCT03657004 - References