Clinical trials: Tacrolimus
Kidney Transplantation
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282568
- Testing
- Tacrolimus Modified Release (MR), tacrolimus
- Where
- 9 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
A Dose Escalation Study in de Novo Renal Transplantation
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Trial name
- NCT04311632
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- ITB-Med LLC
Heart Transplantation, Kidney Transplantation
A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients
The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- PROGRESSION (NCT01371344)
- Testing
- Tacrolimus granules, Tacrolimus capsules
- Where
- 12 sites in Belgium, France and 4 more
- Volunteers
- 47 people
- Sponsor
- Astellas Pharma Europe Ltd.
Atopic Dermatitis
A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis
This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to…
- Trial name
- APPLES (NCT00475605)
- Where
- 313 sites in United States, Austria and 7 more
- Volunteers
- 8,071 people
- Sponsor
- LEO Pharma
Liver Transplantation
A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year…
- Trial name
- COBALT (NCT02143479)
- Testing
- Tacrolimus
- Where
- 18 sites in France
- Volunteers
- 398 people
- Sponsor
- Astellas Pharma S.A.S.
Renal Failure
Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.
Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable…
- Trial name
- NCT01962922
- Testing
- LCP-Tacro, Tacrolimus -IR
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Veloxis Pharmaceuticals
Kidney Transplantation
Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection.
- Trial name
- NCT00263328
- Testing
- Tacrolimus, CP-690,550
- Where
- 27 sites in United States
- Volunteers
- 46 people
- Sponsor
- Pfizer
Graft Rejection, Kidney Transplant
Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.
- Conditions
- Graft Rejection, Kidney Transplant, Renal Allograft Recipients, Renal Transplant
- Trial name
- NCT00895583
- Testing
- Tacrolimus, Sirolimus
- Where
- 44 sites in United States, Argentina and 5 more
- Volunteers
- 254 people
- Sponsor
- Pfizer
Renal Failure
Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules…
- Trial name
- NCT00817206
- Testing
- LCP-Tacro, Prograf
- Where
- United States
- Volunteers
- 326 people
- Sponsor
- Veloxis Pharmaceuticals
Dermatitis Atopic
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate…
- Trial name
- AQUA (NCT06241118)
- Testing
- Amlitelimab, Topical corticosteroids, Topical tacrolimus or pimecrolimus
- Where
- 154 sites in United States, Argentina and 20 more
- Volunteers
- 464 people
- Sponsor
- Sanofi
Kidney Transplantation
Study of Immunosuppressive Therapy Toxicities in Kidney Transplant Recipients at Regional or Satellite Community Clinics
This is a multicentre, observational, non-interventional, retrospective analysis by chart review.
- Trial name
- NCT00902980
- Testing
- Chart Review
- Where
- 13 sites in Canada
- Volunteers
- 264 people
- Sponsor
- Astellas Pharma Inc
High Risk Myeloid Malignancies, Cord Blood Transplant
US Study of ECT-001-CB in Pediatric and Young Adult Patients With High-Risk Myeloid Malignancies
Cord blood (CB) transplants are an option for patients lacking an HLA identical donor but are hampered by low cell dose, prolonged aplasia and high transplant related mortality.
- Trial name
- NCT04990323
- Testing
- ECT-001-CB (UM171-Expanded Cord Blood Transplant)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- ExCellThera inc.
Kidney Transplantation
Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to…
- Trial name
- TWIST (NCT00296348)
- Testing
- tacrolimus, mycophenolate mofetil, daclizumab
- Where
- 35 sites in Belgium, Czechia and 12 more
- Volunteers
- 198 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients
To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients
- Trial name
- NCT00720265
- Testing
- Prograf, MR4
- Where
- 2 sites in South Korea
- Volunteers
- 135 people
- Sponsor
- Astellas Pharma Inc
Hematological Malignancies
A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies
Two part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy (in Part 2 only) of KRP203 in patients undergoing allogeneic hemopoietic stem cell transplant for hematological malignancies
- Trial name
- NCT01830010
- Testing
- Study Part 1: KRP203, Study Part 2: KRP203 lower dose, Study Part 2: KRP203 higher dose
- Where
- 8 sites in France, Germany and 1 more
- Volunteers
- 23 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Kidney Failure, Graft vs Host Disease
Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients
The incidence of efficacy failure at 12 months between two regimens.
- Conditions
- Chronic Kidney Failure, Graft vs Host Disease, Kidney Transplantation
- Trial name
- NCT00044720
- Testing
- Rapamune
- Volunteers
- 484 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Graft Rejection, Kidney Failure
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction…
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplantation
- Trial name
- NCT00261820
- Testing
- tacrolimus, mycophenolate mofetil, methylprednisolone
- Volunteers
- 160 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Glomerulonephritis, Membranous
A Phase 3 Study of Inebilizumab in Participants With Primary Membranous Nephropathy
The primary objective of this study to evaluate the efficacy of inebilizumab on primary membranous nephropathy (PMN) disease activity as measured by complete remission in participants with PMN.
- Trial name
- MOMENT (NCT07851220)
- Testing
- Inebilizumab, Tacrolimus
- Where
- 4 sites in United States
- Volunteers
- 159 people
- Sponsor
- Amgen
Kidney Transplantation
Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient
This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to…
- Trial name
- NCT00452361
- Testing
- Sirolimus+MMF or MPS or AZA+Steroid, Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid
- Where
- Taiwan
- Volunteers
- 31 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
DiGeorge Anomaly, Complete DiGeorge Anomaly
Phase I/II Thymus Transplantation With Immunosuppression #950
The study purpose is to determine if cultured thymus tissue implantation (CTTI) (previously described as transplantation) with tailored immunosuppression based on the recipient's pre-implantation T cell population is a safe and…
- Conditions
- DiGeorge Anomaly, Complete DiGeorge Anomaly, Complete Atypical DiGeorge Anomaly, Complete DiGeorge Syndrome
- Trial name
- #950 (NCT00579527)
- Testing
- Cultured Thymus Tissue for Implantation (CTTI), Cultured Thymus Tissue Implantation and Parental Parathyroid Transplantation, Blood Draw
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH