Immunosuppression Clinical Trial
Official title:
Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial
| Verified date | July 2018 |
| Source | Medical University of Warsaw |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | July 9, 2023 |
| Est. primary completion date | July 9, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: adults 18- 70 after liver transplantation due to liver cirrhosis primary liver transplantation Exclusion Criteria: liver transplantation due to liver cirrhosis and hepatocellular carcinoma (HCC) retransplantation renal impairment Parkinson disease |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Warsaw Medical University | Warsaw |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Warsaw |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | acute rejection | 12 months | ||
| Primary | chronic rejection | 5 years | ||
| Primary | tremor | 12 months | ||
| Primary | de novo diabetes | 5 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05060991 -
Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients
|
Phase 4 | |
| Completed |
NCT02833805 -
NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia
|
Phase 2 | |
| Completed |
NCT01252537 -
Immunosuppression in HIV-infected Patients With Tuberculosis in Ethiopia
|
N/A | |
| Completed |
NCT00621699 -
Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01678937 -
Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents
|
N/A | |
| Completed |
NCT00788021 -
Protective Immunity Project 01
|
N/A | |
| Active, not recruiting |
NCT00166842 -
Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
|
Phase 4 | |
| Recruiting |
NCT05616130 -
Pathological Myeloid Activation After Sepsis and Trauma
|
||
| Completed |
NCT03117192 -
Zinc Supplementation on Cellular Immunity in Thalassemia Major
|
Phase 4 | |
| Recruiting |
NCT01568697 -
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
|
||
| Not yet recruiting |
NCT06024226 -
Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC
|
||
| Not yet recruiting |
NCT04961229 -
Booster Dose of COVID-19 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response
|
Phase 4 | |
| Completed |
NCT03139565 -
High Dose vs. Standard Influenza Vaccine in Adult SOT
|
Phase 3 | |
| Completed |
NCT02547753 -
Dental Extractions Among Renal Transplant Recipients
|
||
| Completed |
NCT01702207 -
Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk
|
Phase 4 | |
| Completed |
NCT00626808 -
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
|
Phase 4 | |
| Completed |
NCT00419575 -
Renal Transplantation With Immune Monitoring
|
N/A | |
| Completed |
NCT00783380 -
Influenza Vaccination in Immunocompromized Patients
|
Phase 4 | |
| Completed |
NCT04835948 -
Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation
|
||
| Recruiting |
NCT05043870 -
Combined Immunosuppression for Pediatric Crohn's Disease
|
Phase 4 |