LCP-tacrolimus administered daily to target a goal trough level of 10-14 ng/mL x 7 months (with Mycophenolate mofetil and prednisone).
Additional standard immunosuppression with either mycophenolate mofetil (500-1500mg twice daily) OR Azathioprine (up to 2mg/kg daily) AND Prednisone (5-10mg daily) will be administered.

IR-tacrolimus administered twice daily to target a goal trough level of 10-14 ng/mL x 7 months (with Mycophenolate mofetil and prednisone). This is currently the standard of care at Vanderbilt University Medical Center and most other lung transplant centers (ISHLT Registry 2019).
Additional standard immunosuppression with either mycophenolate mofetil (500-1500mg twice daily) OR Azathioprine (up to 2mg/kg daily) AND Prednisone (5-10mg daily) will be administered.

Lung Transplant; Complications

Immunosuppression regimen with Tacrolimus Extended Release as the backbone.

Tacrolimus Extended Release Oral Tablet [Envarsus]

Standard Immunosuppression regimen with Intermediate-Release Tacrolimus.

Tacrolimus

Standard immunosuppression of the anti-proliferative class.

Mycophenolate Mofetil Hydrochloride

Standard immunosuppression (corticosteroid class).

Prednisone

Azathioprine

Vanderbilt University Medical Center

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

A Prospective, Randomized, Controlled Pilot Study of Early-Use Long Acting Tacrolimus (Envarsus XR) in Lung Transplant Recipients

Composite of mortality, allograft failure, potential drug induced liver injury, supra-therapeutic trough levels (>20 ng/mL), sub-therapeutic trough levels (<5 ng/mL), seizures, encephalopathy, thrombotic microangiopathy and serious hyperkalemia associated with use of LCP-tacrolimus, compared to matched historical controls administered IR-tacrolimus.

Median change in eGFR from study start to 9 months post-transplantation with patients administered LCP-tacrolimus compared to IR-tacrolimus.

Quality of life related to headache frequency and severity using the Headache Impact Tool (HIT-6).

Quality of life related to tremor as measured by the QUEST tool.

Incidence of acute cellular rejection (>= A1) or lymphocytic bronchiolitis (>= B1R)

Incidence of de novo donor-specific anti-HLA antibodies (MFI > 1500) within the first 9 months post-transplant.

Anil Trindade

Assistant Professor of Medicine

Veloxis Pharmaceuticals

Prospective, randomized, controlled pilot study.

Patients assigned to this arm will continue their nucleos(t) analogue

Patients assigned to this arm will continue their existing nucleos(t)ide therapy and also be assigned peg-interferon alpha 2b 1.5mcg/kg sc weekly

Patients assigned to this arm will stop their existing nucleos(t)ide therapy after one month overlap after starting peg-interferon alpha 2b 1.5mcg/kg sc weekly

Chronic Hepatitis B

peg-interferon alpha 2b, 1.5mcg/kg s/c given weekly

Nucleos(t)ide analogue therapy

Changi General Hospital

National University Hospital

Singapore General Hospital

Tan Tock Seng Hospital

Efficacy of Switching or Adding Pegylated Interferon in Chronic Hepatitis B Patients on Long Term Oral Antiviral Therapy

SWITCH OR ADD PEGYLATED-INTERFERON IN CHRONIC HEPATITIS B PATIENTS ON LONG TERM NUCLEOS(T)IDE THERAPY (SWAP TRIAL)

Seng Gee Lim

Director of Hepatology, Dept of Gastroenterology and Hepatology

Singapore Clinical Research Institute

Merck Sharp & Dohme Corp.

Three arm parallel study randomised 1:2:2

pulmonary fibrosis/seizures

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

Efficacy of Switching or Adding Pegylated Interferon in Chronic Hepatitis B Patients on Long Term Oral Antiviral Therapy

PIoglitazone for PrEvention of Restenosis in Diabetic Patients

SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole

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