Clinical trials: Transplantation, Kidney
Acute Renal Failure
Low Dose Thymoglobin in Renal Transplant Patients
This is a planned single center prospective randomized study evaluating the safety and efficacy of low dose thymoglobulin as induction agent in renal transplant recipients.
- Trial name
- NCT01280617
- Testing
- Thymoglobulin, Thymoglobulin 0.75mg/kg dose
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Lahey Clinic
Kidney Transplant Failure and Rejection
Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients
The primary objective is to compare the effect of treatment with an immediate-release tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen on cognitive and motor function in kidney…
- Trial name
- NCT03437577
- Testing
- immediate-release tacrolimus, extended release tacrolimus
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Minnesota
Graft Rejection
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
- Trial name
- NCT01147302
- Testing
- C1 Esterase Inhibitor (Human)
- Where
- 5 sites in United States, Germany
- Volunteers
- 18 people
- Sponsor
- Shire
Kidney Transplantation
Efficacy of Belatacept in Reducing DSA
The primary objective of this study is to demonstrate that administration of belatacept in maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody (DSA).
- Trial name
- NCT02078193
- Testing
- Belatacept
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- East Carolina University
Surgical Site Reaction
The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects
This study is being conducted to see how safe and effective the Prevena Incision Management System "Prevena" is when placed over a renal transplantation incision. Prevena provides negative pressure (suction) wound therapy.
- Trial name
- PIMS (NCT01341444)
- Testing
- Prevena Incision Management System, Standard of Care for Surgical Incisions
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- KCI USA, Inc
Organ Transplantation
Belatacept Post Depletional Repopulation to Facilitate Tolerance
Acute rejection is a common problem after a kidney transplant. Rejection can occur when the kidney recipient's immune system tries to attack (or reject) the new kidney.
- Trial name
- NCT00565773
- Testing
- Belatacept, Sirolimus, Alemtuzumab
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Allan D Kirk, MD, PhD
Renal Transplant
Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients
The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.
- Trial name
- NCT01256294
- Testing
- Generic Tacrolimus, Branded Tacrolimus
- Where
- 2 sites in United States
- Volunteers
- 71 people
- Sponsor
- Novartis
Kidney Transplantation
Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy
The 3C study is investigating whether reducing exposure to calcineurin inhibitors (by using more potent antibody induction treatment and/or an elective switch to sirolimus) can improve the function and survival of kidney…
- Trial name
- 3C (NCT01120028)
- Testing
- Alemtuzumab, Basiliximab, Sirolimus
- Where
- 20 sites in United Kingdom
- Volunteers
- 852 people
- Sponsor
- University of Oxford
Renal Transplanted Recipients
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and…
- Trial name
- NCT00371826
- Testing
- Everolimus (RAD001), Cyclosporine (Calcineurin Inhibitor (CNI)), Methylprednisone/prednisone
- Where
- 7 sites in Australia
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Myeloma, Amyloidosis
Combined Bone Marrow and Renal Transplantation for Hematologic Disorders With End Stage Renal Disease
This pilot trial offers the unique opportunity for both the treatment of multiple myeloma or systemic AL amyloidosis for which hematopoietic stem cell transplantation would be ordinarily indicated and the reversal of end-stage…
- Trial name
- NCT02158052
- Testing
- Tacrolimus, Equine Anti-thymocyte globulin, Kidney transplant from a related donor
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Massachusetts General Hospital
Liver Transplantation
Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate…
- Trial name
- RAD (NCT00622869)
- Testing
- Tacrolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination), Tacrolimus (tacrolimus control)
- Where
- 91 sites in United States, Argentina and 17 more
- Volunteers
- 719 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation
Behavioral Contract Adherence Intervention
There is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and clinical outcomes.
- Trial name
- NCT01739803
- Testing
- Behavioral Contract
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Tennessee
Kidney Transplant
Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Crossmatch Deceased Donor Kidney Transplant
The purpose of this study is to test whether a dosing regimen of eculizumab in addition to standard posttransplant care in positive crossmatch deceased donor kidney transplant recipients will reduce the incidence of acute humoral…
- Trial name
- NCT01106027
- Testing
- Eculizumab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Mayo Clinic
Renal Transplantation
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects
- Trial name
- NCT02564497
- Testing
- Process E Belatacept, Process C Belatacept
- Where
- United States
- Volunteers
- 491 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Liver Failure
Study to Evaluate if the Drug Vasopressin Protects the Kidneys for Patients Undergoing Liver Transplant
The purpose of this study is evaluate the medication vasopressin for its ability to preserve kidney function in patients undergoing liver transplantation.
- Trial name
- NCT00886262
- Testing
- Vasopressin
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV)…
- Trial name
- NCT02251717
- Testing
- LDV/SOF
- Where
- 5 sites in Austria, France and 2 more
- Volunteers
- 114 people
- Sponsor
- Gilead Sciences
Lung Transplantation
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients
This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.
- Trial name
- 4EVERLUNG (NCT01404325)
- Testing
- standard therapy, Everolimus
- Where
- 9 sites in Germany
- Volunteers
- 130 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Recipients
Immune Monitoring and CNI Withdrawal in Low Risk Recipients of Kidney Transplantation
The study will compare how well transplanted kidneys work and the response of people's immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn.
- Trial name
- NCT01517984
- Testing
- Tacrolimus (CNI) Withdrawal, Standard Immunosuppressive Therapy
- Where
- 11 sites in United States, Canada
- Volunteers
- 52 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Immunosuppression
Thymoglobulin Induction Therapy With Minimal Immunosuppression and Evaluation of Allograft Status
Tacrolimus (Prograf) is a medication that is commonly used in patients who receive a kidney transplant. It is considered to be one of the most important medications that prevent rejection of the transplant kidney by suppressing…
- Trial name
- TIMELY (NCT00731874)
- Testing
- Tacrolimus
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Weill Medical College of Cornell University
Kidney Transplant
A Study Of CP-690,550 In Stable Kidney Transplant Patients
This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients.
- Trial name
- NCT01710033
- Testing
- CP-690,550 5 mg BID, CP-690,550 15 mg BID, CP-690,550 30 mg BID
- Where
- 11 sites in United States
- Volunteers
- 28 people
- Sponsor
- Pfizer