Clinical trials: Kidney Transplant Immunosuppression
Kidney Transplantation
Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts
This is a multicentre study examining the use of Advagraf-minimization strategy and/or the use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal allografts.
- Trial name
- NCT00933231
- Testing
- tacrolimus, Simulect, Cellcept
- Where
- 13 sites in Canada
- Volunteers
- 281 people
- Sponsor
- Astellas Pharma Inc
Disorder Related to Renal Transplantation
Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity.
The objective is to assess if low pre-transplantation donor specific T-cell reactive patients measured by Enzyme-linked immunosorbent spot (ELISPOT)assay can be safely managed with Calcineurin inhibitor(CNI)-free…
- Trial name
- SIRES (NCT01195194)
- Testing
- PRE-TRANSPLANT (PRE=before)
- Where
- 2 sites in Spain
- Volunteers
- 61 people
- Sponsor
- Josep M Grinyo
Kidney Transplantation
A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients
Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day dosing regimen. This formulation has the potential to improve compliance.
- Trial name
- Tacrolimus ER (NCT02444143)
- Testing
- tacrolimus extended release
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Illinois Chicago
Transplant, Kidney
Pilot Trial for Implementation of a MPA PK Monitoring Strategy
This study is a prospective interventional trial of de novo renal transplant recipients, aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling, and subsequent MPA trough level monitoring…
- Trial name
- MPA (NCT00187915)
- Testing
- Mycophenolate mofetil + Tacrolimus, Mycophenolate mofetil + Cyclosporin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Florida
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
Pediatric Kidney Disease, Transplant;Failure,Kidney
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Currently, the monitoring of children receiving a kidney transplantation includes surveillance biopsies to detect subclinical rejection and signs of toxicity of immunosuppressive drugs (tacrolimus).
- Trial name
- MONITOR (NCT06761482)
- Testing
- monitoring by dd-cfDNA, monitoring by T-Vis, monitoring by dd-cfDNA+ T-Vis
- Where
- France
- Volunteers
- 160 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Liver Transplantation
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g.
- Trial name
- NCT02736227
- Testing
- Tacrolimus Withdrawal and Everolimus Monotherapy
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Northwestern University
Kidney Transplantation
Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
- Trial name
- NCT00492869
- Testing
- AEB071
- Where
- 41 sites in United States, Belgium and 5 more
- Volunteers
- 124 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction
Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection.
- Trial name
- NCT05086003
- Testing
- Combined kidney and bone marrow transplantation
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Rabin Medical Center
Kidney Transplant
Patient Reported Outcomes in Renal Transplant Patients Tolerating Gastrointestinal (GI) Symptoms Converted to Myfortic (EC-MPS)
Hypothesis: Presently, some patients' mycophenolate mofetil (MMF.,Cellcept) related gastrointestinal (GI) symptoms are not being spontaneously reported.
- Trial name
- NCT00676221
- Testing
- Myfortic
- Where
- Canada
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Foothills Medical Centre
Renal Transplant Recipients
Research Study of ATG and Rituximab in Renal Transplantation
The purpose of this study is see if a combination of two drugs, (ATG and rituximab), given at the time of the transplant surgery, will help reduce or eliminate the need for long term immunosuppressive medication.
- Trial name
- RESTARRT (NCT01318915)
- Testing
- ATG, Rituximab, Tacrolimus
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Kidney Transplantation, Immunity
Protective Immunity Project 01
Patients who undergo kidney transplant must take medications to prevent organ rejection. There are standard immunosuppressant medications such as prednisone, tacrolimus (Prograf), mycophenolate mofetil(Cellcept) or sirolimus…
- Conditions
- Kidney Transplantation, Immunity, Immunosuppression
- Trial name
- PIP-01 (NCT00788021)
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Emory University
COVID-19, Immunosuppression
Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients
Immunocompromised individuals, such as solid organ transplant (SOT) recipients are at high risk of COVID-19 associated complications and mortality.
- Conditions
- COVID-19, Immunosuppression, Vaccine Response Impaired
- Trial name
- ADIVKT (NCT05060991)
- Testing
- Reduction in antimetabolite immunosuppression
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of California, Davis
Kidney Transplant; Complications
Once Daily Immunosuppression Regimen
The purpose of this research study is to determine whether an immunosuppressive maintenance regimen of Envarsus/azathioprine compared to a tacrolimus/ mycophenolic acid regimen is associated with better compliance, tolerability…
- Trial name
- NCT03555448
- Testing
- Once daily immunosuppression regimen, Twice daily immunosuppression regimen
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Washington University School of Medicine
Kidney Transplantation, Chronic Kidney Failure
Early Conversion From Tacrolimus to Efalizumab Maintenance Therapy in Kidney Transplant Recipients
The toxicity of calcineurin inhibitors(CNI)is a major factor limiting the success of renal transplantation. This protocol aims to replace the calcineurin inhibitor, tacrolimus, with efalizumab early after transplantation in…
- Trial name
- NCT00472082
- Testing
- efalizumab
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Emory University
Kidney Transplantation
Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients
To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects Primary endpoints: 1.
- Trial name
- OPTIMUM (NCT01159080)
- Testing
- routine dose tacrolimus and less myfortic, reduced dose tacrolimus and conventional myfortic
- Where
- South Korea
- Volunteers
- 350 people
- Sponsor
- Asan Medical Center
Pancreas-Kidney Transplantation
Simultaneous Pancreas-kidney Transplantation With Campath Protocol
The purpose of this study is to determine and compare the efficacy of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF therapy in conjunction with initial short-term steroids in Type 1-diabetic patients undergoing simultaneous…
- Trial name
- NCT00316810
- Testing
- Alemtuzumab, Rabbit Anti-Human Thymocyte Globulin
- Where
- Austria
- Volunteers
- 30 people
- Sponsor
- Dr. Claudia Bösmüller
Kidney Transplant, Immunology
Protective Immunity Project 02
Influenza (Flu) vaccine is recommended for kidney transplant patients who are at least 6 months post-transplant. The influenza vaccine stimulates the immune system to builds protective antibodies against the flu virus.
- Conditions
- Kidney Transplant, Immunology, Immunosuppression
- Trial name
- PIP-02 (NCT00833651)
- Where
- United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Emory University
Kidney Transplant Rejection, Kidney Transplant Infection
Dynamic Changes of Torquetenovirus (TTV) Load in Chinese Renal Transplant Recipients
The goal of this observational study is to learn about dynamic changes of Torquetenovirus (TTV) load in Chinese renal transplant recipients.
- Conditions
- Kidney Transplant Rejection, Kidney Transplant Infection, Virus, Immunosuppression
- Trial name
- TTV (NCT05727709)
- Where
- 5 sites in China
- Volunteers
- 220 people
- Sponsor
- Tongji Hospital