Clinical trials: Immune Suppression
Kidney Transplantation
A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids
The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.
- Trial name
- ADVANCE (NCT01304836)
- Testing
- Advagraf, Mycophenolate Mofetil, Simulect
- Where
- 100 sites in Australia, Belgium and 22 more
- Volunteers
- 1,166 people
- Sponsor
- Astellas Pharma Inc
Transplantation Infection
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients…
- Trial name
- EVEREST (NCT01276457)
- Testing
- Everolimus 0.25 and 0.75 mg tablets, Cyclosporine very low dose (150-300 ng/mL) microemulsion, Cyclosporine low dose (350-500 ng/mL) microemulsion
- Volunteers
- 223 people
- Sponsor
- Novartis Pharmaceuticals
HIV Infections
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count <250 cells/mm3 and an HIV RNA viral load <400 copies/mL.
- Trial name
- NCT00461266
- Testing
- enfuvirtide [Fuzeon], Antiretroviral therapy
- Where
- 7 sites in Australia
- Sponsor
- Hoffmann-La Roche
Immunosuppression Management, Biomarkers / Blood
PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)
This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring. Approximately 15 U.S. sites
- Conditions
- Immunosuppression Management, Biomarkers / Blood, Subclinical Rejection, Biopsy
- Trial name
- PIONEER (NCT07231328)
- Testing
- There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection.
- Volunteers
- 600 people
- Sponsor
- Transplant Genomics, Inc.
HIV, Human Immunodeficiency Virus
An Extension of Protocol PRO 140_CD01 Study
This is an extension of Protocol PRO 140_CD 01 to further evaluate the long-term suppression of HIV-1 replication following substitution of stable combination antiretroviral therapy with a PRO 140 (Monoclonal CCR5 antibody)…
- Trial name
- NCT02355184
- Testing
- PRO 140 350mg weekly subcutaneous (SC) injection.
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- CytoDyn, Inc.
Heart Transplant, Immunosuppression
HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)
This is an unblinded, randomized, controlled, two-arm interventional research study enrolling patients who are undergoing heart transplantation.
- Conditions
- Heart Transplant, Immunosuppression, Allograft
- Trial name
- MOSAIC (NCT05459181)
- Testing
- HeartCare
- Volunteers
- 930 people
- Sponsor
- CareDx
Kidney Transplant
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.
- Trial name
- NCT01025817
- Testing
- Everolimus and tacrolimus, mycophenolate mofetil and tacrolimus
- Where
- 50 sites in United States, Canada
- Volunteers
- 613 people
- Sponsor
- Novartis Pharmaceuticals
Liver Failure
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients.
- Trial name
- LTA (NCT05744635)
- Testing
- Tacrolimus
- Where
- 2 sites in Hungary, Slovenia
- Volunteers
- 110 people
- Sponsor
- Chiesi Hungary Ltd.
DiGeorge Syndrome, DiGeorge Anomaly
Thymus Transplantation With Immunosuppression
The research purpose is to determine if thymus transplantation with immunosuppression is a safe and effective treatment for complete DiGeorge anomaly.
- Conditions
- DiGeorge Syndrome, DiGeorge Anomaly, Complete DiGeorge Anomaly, Complete DiGeorge Syndrome
- Trial name
- 884 (NCT00579709)
- Testing
- Thymus Tissue for Transplantation
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Kidney Transplantation
A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.
The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.
- Trial name
- ADHERE (NCT01363752)
- Testing
- Advagraf, Mycophenolate Mofetil, Sirolimus
- Where
- 58 sites in Australia, Austria and 15 more
- Volunteers
- 853 people
- Sponsor
- Astellas Pharma Inc
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.
Acute Kidney Injury Due to Sepsis
Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)
The purpose of this Ph2b study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses of TIN816 in hospitalized adult participants in an intensive care setting…
- Trial name
- CLEAR-AKI (NCT05996835)
- Testing
- TIN816 70 mg lyophilisate powder
- Where
- 79 sites in United States, Argentina and 15 more
- Volunteers
- 316 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.
To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.
- Trial name
- MARSILEA (NCT00295594)
- Testing
- tacrolimus
- Where
- 41 sites in Belgium, Denmark and 9 more
- Volunteers
- 627 people
- Sponsor
- Astellas Pharma Inc
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
AML, CML
Safety Study of IL-7 in Recipients of a Hemopoietic Stem Cell Transplant Peripheral Blood Stem Cell Transplant
This is a phase I inter-patient dose escalation open labeled study assessing multiple doses of CYT107 in patients of at least 15 years of age, who are recipients of HLA matched ex vivo T cell depleted bone marrow or peripheral…
- Conditions
- AML, CML, MDS
- Trial name
- NCT00684008
- Testing
- CYT107 - Recombinant glycosylated human interleukin 7., rhIL-7 (CYT107)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Cytheris, Inc.
Infection, Human Immunodeficiency Virus, HIV Infections
A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects
This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA…
- Trial name
- NCT02120352
- Testing
- CAB Oral Tablets, CAB LA, ABC/3TC Oral tablets
- Where
- 50 sites in United States, Canada and 3 more
- Volunteers
- 309 people
- Sponsor
- ViiV Healthcare
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
HIV Infections
A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs
The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF.
- Trial name
- NCT00002411
- Testing
- Nelfinavir mesylate, Lamivudine, Stavudine
- Where
- 32 sites in United States
- Sponsor
- Bristol-Myers Squibb
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
HIV Infections
Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC…
- Trial name
- NCT00002429
- Testing
- Lamivudine/Zidovudine, Nelfinavir mesylate, Stavudine
- Where
- 23 sites in United States, Canada
- Volunteers
- 500 people
- Sponsor
- Bristol-Myers Squibb