Clinical trials: Immunosuppression
Lupus Nephritis
Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis
The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.
- Trial name
- NCT00709722
- Testing
- NKT-01
- Where
- 6 sites in Czechia, Germany
- Volunteers
- 21 people
- Sponsor
- Nippon Kayaku Co., Ltd.
Kidney Transplantation
A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients
A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
- Trial name
- NCT00282230
- Testing
- FK778
- Where
- 23 sites in United States
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Inc
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
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
Renal Transplantation
Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation
The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant.
- Trial name
- INSPIRE (NCT01586845)
- Testing
- voclosporin, tacrolimus
- Sponsor
- Aurinia Pharmaceuticals Inc.
Renal Transplantation
Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended…
- Trial name
- BENEFIT-EXT (NCT00114777)
- Testing
- Cyclosporin A, Belatacept Less Intensive Regimen (LI), Belatacept More Intensive Regimen (MI)
- Where
- 79 sites in United States, Argentina and 17 more
- Volunteers
- 595 people
- Sponsor
- Bristol-Myers Squibb
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
Liver Transplantation
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282256
- Testing
- tacrolimus modified release (MR), tacrolimus
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- Astellas Pharma Inc
de Novo Kidney Transplant Recipients, Renal Transplantation
Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.
This study will compare the following immunosuppressive regimens in recipients of kidney transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and cyclosporine given twice a day with steroid…
- Trial name
- EVIDENCE (NCT01023815)
- Testing
- everolimus, cyclosporine, Prednison (continuous steroids)
- Where
- 28 sites in Italy
- Volunteers
- 330 people
- Sponsor
- Novartis
Liver Failure
Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients
The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by…
- Trial name
- NCT00772148
- Testing
- LCP -Tacro, Prograf
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Veloxis Pharmaceuticals
Renal Transplant Rejection
Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids
The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept®…
- Trial name
- IBERICA (NCT01324934)
- Testing
- ATG-Fresenius S
- Where
- 10 sites in Portugal, Spain
- Volunteers
- 40 people
- Sponsor
- Neovii Biotech
Kidney Diseases
Study of ISA247 (Voclosporin) in De Novo Renal Transplantation
This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.
- Trial name
- PROMISE (NCT00270634)
- Testing
- Voclosporin, tacrolimus
- Where
- 45 sites in United States, Canada
- Volunteers
- 334 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Kidney Transplantation
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
- Trial name
- NCT00099736
- Testing
- FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids, MMF 2 g + full-dose Neoral (FDN) + corticosteroids
- Where
- 42 sites in United States
- Volunteers
- 696 people
- Sponsor
- Novartis Pharmaceuticals
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
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection…
- Trial name
- NCT00885820
- Testing
- Tacrolimus, MMF, Corticosteroids (Prednisone)
- Where
- 12 sites in United States, Canada
- Volunteers
- 240 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection
The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.
- Trial name
- NCT00133172
- Testing
- Tacrolimus, mycophenolate mofetil, Prednisone
- Where
- 14 sites in Canada
- Volunteers
- 85 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplant Rejection
CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM…
- Trial name
- CLARITY (NCT05482100)
- Testing
- Patients monitored with OmniGraf testing
- Volunteers
- 500 people
- Sponsor
- Transplant Genomics, Inc.
Atherosclerosis, Kidney Failure
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of…
- Trial name
- NCT00311311
- Testing
- tacrolimus, mycophenolate mofetil, prednisone
- Where
- 8 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Pfizer
Renal Transplant Failure and Rejection
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
The goal of this clinical trial is to learn if siplizumab can prevent rejection of a kidney transplant in adult participants with end stage kidney disease.
- Trial name
- MODERNIZE1 (NCT07508787)
- Testing
- Siplizumab, Rabbit anti-thymocyte globulin
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 120 people
- Sponsor
- Nefro Avillion Clinical Development, LLC
Diabetes Mellitus
Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes
This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function.
- Trial name
- NCT00064714
- Testing
- AC2993 (exenatide), daclizumab (immunosuppressive)
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- AstraZeneca