Clinical trials: Decreased Immunologic Activity
Uveitis
Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis
This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.
- Trial name
- INSURE (NCT01095250)
- Testing
- AIN457
- Where
- 36 sites in United States, Canada and 11 more
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.
- Trial name
- NCT01820572
- Testing
- Belatacept, Tacrolimus, Cyclosporine
- Where
- 117 sites in United States, Argentina and 8 more
- Volunteers
- 446 people
- Sponsor
- Bristol-Myers Squibb
Immunosuppression, Rheumatism
To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.
- Trial name
- NCT00946790
- Testing
- Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.), Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Sandoz
Intestine Transplantation, Kidney Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.
- Conditions
- Intestine Transplantation, Kidney Transplantation, Lung Transplantation, Liver Transplantation
- Trial name
- NCT01294020
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 16 sites in Belgium, Czechia and 5 more
- Volunteers
- 81 people
- Sponsor
- Astellas Pharma Europe Ltd.
Kidney Transplantation
24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients
This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.
- Trial name
- NCT00555789
- Testing
- AEB071, mycophenolic plus tacrolimus
- Where
- 27 sites in United States, Canada and 6 more
- Volunteers
- 137 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation, Renal Transplantation
A Study to Evaluate FK778 in Kidney Transplant Patients
A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients
- Conditions
- Kidney Transplantation, Renal Transplantation, Transplantation, Renal, Transplantation, Kidney
- Trial name
- NCT00189735
- Testing
- FK778
- Where
- 37 sites in Austria, Belgium and 10 more
- Volunteers
- 364 people
- Sponsor
- Astellas Pharma Inc
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.
Kidney Transplantation, Kidney Failure, Chronic
Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.
- Conditions
- Kidney Transplantation, Kidney Failure, Chronic, Renal Insufficiency, Chronic
- Trial name
- NCT00717379
- Testing
- Tacrolimus, Mycophenolate Mofetil, Methylprednisolone or equivalent
- Where
- 6 sites in Russia
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor…
- Trial name
- RETIRE (NCT06552169)
- Testing
- Arm 1: SOC (mTOR + CNI), Arm 2A: TRACT/MONO mTOR, Arm 2B: TRACT/MONO CNI
- Where
- 7 sites in United States, Taiwan
- Volunteers
- 34 people
- Sponsor
- Singulera Therapeutics Inc.
Non-Melanoma Skin Carcinoma
Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009g
The primary objective of the study is to assess the relationship (both crude and adjusted) between voriconazole utilization and the development of non-melanoma skin cancer among adult patients who received a lung or heart/lung…
- Trial name
- NCT01480219
- Testing
- voriconazole (Vfend), no voriconazole (Vfend)
- Volunteers
- 467 people
- Sponsor
- Pfizer
Psoriasis
Randomized, Placebo and Ciclosporin Controlled Study of ISA247 in Plaque Psoriasis Patients
The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis.
- Trial name
- ESSENCE (NCT00408187)
- Testing
- voclosporin, Ciclosporin
- Where
- 49 sites in Canada, Germany and 1 more
- Volunteers
- 642 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Kidney Transplantation
Regimen Optimization Study
Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress the immune system (called immunosuppressive regimens) to stop the immune system from attacking the transplanted kidney in order to limit…
- Trial name
- NCT02137239
- Testing
- Thymoglobulin, Belatacept, mycophenolate mofetil(MMF)
- Where
- 20 sites in United States, Argentina
- Volunteers
- 58 people
- Sponsor
- Bristol-Myers Squibb
Immunosuppression For Disease
Absorption, Distribution, Metabolism and Excretion (ADME) Study of BMS-986020
The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, as well as safety and tolerability of a single oral solution dose of [14C] Bristol-Myers Squibb (BMS)-986020 in…
- Trial name
- NCT02068053
- Testing
- [14C] BMS-986020
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Heart Transplantation, Lung Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery.
- Conditions
- Heart Transplantation, Lung Transplantation, Pancreas (Including SPK) Transplantation
- Trial name
- NCT01332201
- Testing
- Advagraf, Prograf
- Where
- 8 sites in Austria, Belgium and 4 more
- Volunteers
- 17 people
- Sponsor
- Astellas Pharma Inc
Phenylketonuria
Immune Modulation During Palynziq® Treatment in Adults (IMPALA)
Study 165-401 is a Phase 4, open-label study designed to examine the concomitant use of methotrexate (MTX) to suppress immune responses to Palynziq and improve tolerability and efficacy in adults with PKU.
- Trial name
- NCT07477691
- Testing
- Pegvaliase, Methotrexate
- Where
- 12 sites in United States
- Volunteers
- 12 people
- Sponsor
- BioMarin Pharmaceutical
Immunosuppression For Disease
Drug Interaction Study With Rosuvastatin
The purpose of this study is to evaluate the effect of concomitant administration of BMS-986020 on the single dose Pharmacokinetics (PK) of Rosuvastatin in healthy subjects.
- Trial name
- NCT02101125
- Testing
- BMS-986020, Rosuvastatin
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Immunosuppression
Bioequivalence Study of Tacrobell Capsule 1mg to Prograf Capsule 1mg
The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and prograf capsule 1mg.
- Trial name
- NCT01910077
- Testing
- Tacrobell capsule 1mg, Prograf capsule 1mg
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Kidney Transplant
First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients
This first in human study aims at evaluating LIS1, a stabilized solution of purified anti-T lymphocytes polyclonal glyco-humanized swine IgG with immunosuppressive activity, in regards of safety, T cell depletion, and…
- Trial name
- NCT04431219
- Testing
- LIS1
- Where
- Czechia
- Volunteers
- 10 people
- Sponsor
- Xenothera SAS
Clostridium Difficile
A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System
The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.
- Trial name
- FREEDOM (NCT01775397)
- Testing
- Fidaxomicin, Vancomycin
- Where
- 16 sites in Austria, Denmark and 5 more
- Volunteers
- 12 people
- Sponsor
- Astellas Pharma Europe Ltd.
KIDNEY TRANSPLANTATION
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids versus tacrolimus plus MMF, following induction with…
- Trial name
- TIGRE (NCT00321113)
- Testing
- tacrolimus, mycophenolate mofetil, steroids
- Where
- 14 sites in Italy
- Volunteers
- 142 people
- Sponsor
- Astellas Pharma Inc