Clinical trials: Kidney Transplantation in Highly Sensitized Patients
End Stage Renal Disease (ESRD)
A Safety Study of Tocilizumab to Improve Transplant Rates in Highly Sensitized Patients Awaiting Kidney Transplantation
In this Phase I/II trial, 10 highly sensitized patients will be entered after informed consent and will receive Intravenous Immunoglobulin (IVIG) at 2 gm/kg + Tocilizumab 8 mg/kg x 5 doses on days 15, 45, 75, 105, 119, 135, and…
- Trial name
- NCT01594424
- Testing
- Tocilizumab, Intravenous Immunoglobulin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cedars-Sinai Medical Center
Kidney Disease, Kidney Transplant
Immunological Reset to Allow Access to HLA Compatible Transplantation in Highly Sensitized Kidney Transplant Candidates Through Non-myeloablative Autologous Stemm Cell Transplantation
This is a study for hypersensitized patients who have been waiting for more than 3 years for an offer for a kidney transplant. The objective is to perform a transplant of autologous hematopoietic precursors with the aim of…
- Conditions
- Kidney Disease, Kidney Transplant, Kidney Transplant Candidates
- Trial name
- RESET (NCT06809075)
- Testing
- hematopoietic precursor transplantation (TPHa)
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Kidney Transplantation in Highly Sensitized Patients
Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys
The goal of this follow-up study is to learn about long-term patient survival and graft function in highly sensitized patients who have received desensitization treatment with imlifidase or standard of care (SoC) in order to…
- Trial name
- ConfIdeSLTFU (NCT05714514)
- Testing
- Imlifidase administered in the ConfIdeS study, Best available treatment administered in the ConfIdeS study
- Where
- 14 sites in United States
- Volunteers
- 64 people
- Sponsor
- Hansa Biopharma AB
Kidney Transplant, Kidney Failure
CAR-T Cell Therapy for Desensitization in Kidney Transplantation
This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher.
- Conditions
- Kidney Transplant, Kidney Failure, End Stage Renal Failure on Dialysis
- Trial name
- NCT06056102
- Testing
- Cyclophosphamide, CART-BCMA, huCART19
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Renal Disease
Ides in Highly Sensitized (HS) Patients Awaiting Kidney Transplantation
This is a single center phase I/II open label, exploratory study assessing safety and efficacy of IdeS® (Hansa Medical, Lund, Sweden) given immediately prior to kidney transplantation.
- Trial name
- NCT02426684
- Testing
- IdeS® (Imlifidase)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Cedars-Sinai Medical Center
Kidney Failure, Chronic, End-Stage Renal Disease
Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant…
- Conditions
- Kidney Failure, Chronic, End-Stage Renal Disease, Transplant Glomerulopathy, Transplant;Failure,Kidney
- Trial name
- NCT03380962
- Testing
- Clazakizumab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stanley Jordan, MD
Kidney Transplantation in Highly Sensitized Patients
Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts
An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease (ESRD) patients with positive crossmatch (XM) against a deceased donor prior…
- Trial name
- PAES (NCT05369975)
- Testing
- Imlifidase, Normal Transplantation Routine
- Where
- 22 sites in Austria, Belgium and 9 more
- Volunteers
- 113 people
- Sponsor
- Hansa Biopharma AB
Kidney Transplantation
Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection
Organ transplantation offers the only hope for a normal life for patients with end-stage renal disease on dialysis (ESRD). For the highly-sensitized patient, patients with antibodies to human leukocyte antigens (HLA)…
- Trial name
- NCT01134510
- Testing
- C1 Esterase Inhibitor
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stanley Jordan, MD
Kidney Failure, Chronic, Diabetic Nephropathies
Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant
This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone.
- Conditions
- Kidney Failure, Chronic, Diabetic Nephropathies, Glomerulonephritis, IGA, Hypertension, Renal
- Trial name
- NCT00446251
- Testing
- Rituximab, Mycophenolate mofetil (MMF)
- Volunteers
- 14 people
- Sponsor
- University of Washington
End-Stage Renal Disease, Kidney Transplantation
An Evaluation of IV Gamma Globulin As a Method to Improve Kidney Transplant Survival in Patients With End-Stage Renal Disease Who Are Highly Sensitized to Transplant Antigens
This study is designed to test the clinical and laboratory observations that suggest IVIG given before and after kidney transplant to patients who are sensitized (highly sensitive) to certain transplant antigens could result in…
- Trial name
- NCT00000935
- Testing
- Intravenous immune globulin (IVIG)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Highly Sensitized Patients Awaiting Kidney Transplant
OM336 in Sensitized Transplant Candidates
This investigator-initiated, single-arm, open-label Phase IIa pilot study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OM336 in highly HLA-sensitized adults with chronic…
- Trial name
- NCT07789431
- Testing
- OM3436
- Where
- 2 sites in Austria, Germany
- Volunteers
- 12 people
- Sponsor
- Medical University of Vienna
Kidney Transplantation in Highly Sensitized Patients
Imlifidase Prior to Kidney Transplant in Highly Sensitised Children
The goal of this clinical trial is to learn about the efficacy and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD).
- Trial name
- DINKY (NCT05753930)
- Testing
- Imlifidase
- Where
- 6 sites in Finland, France and 3 more
- Volunteers
- 10 people
- Sponsor
- Hansa Biopharma AB
Kidney Transplant Rejection
Immune Response in Desensitized Patients
Kidney transplantation is the best treatment for chronic renal failure in terms of morbidity and mortality, quality of life for patients and health economics.
- Trial name
- DELIGHT (NCT05785936)
- Testing
- Desensitization
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Grenoble
End Stage Renal Disease
Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation
This single center, Phase I/II, exploratory study has been modified to a safety/efficacy study providing all patients with IVIG and Rituximab.
- Trial name
- NCT01178216
- Testing
- Rituxan
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Stanley Jordan, MD
Kidney Transplantation in Highly Sensitized Patients
Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx
An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization…
- Trial name
- ConfIdeS (NCT04935177)
- Testing
- Imlifidase, PLEX, IVIg
- Where
- 25 sites in United States
- Volunteers
- 64 people
- Sponsor
- Hansa Biopharma AB
Sensitisation, Highly Sensitised Dialysis Patients
The Safety/Efficacy Of Daratumumab With Belatacept In Highly HLA-Sensitized Patients Awaiting Kidney Transplantation
While the number of kidney transplants is increasing worldwide every year, there is a clear imbalance between the high number of patients in the waiting list and those receiving a transplant and importantly, among waitlist…
- Trial name
- COMBAT (NCT05145296)
- Testing
- Each patient will undergo in the first step of the study belatacept treatment and in the second apheresis and daratumumab
- Where
- France
- Volunteers
- 5 people
- Sponsor
- University Hospital, Grenoble
Highly-sensitized Kidney Transplant Recipients
Role of Everolimus in Highly Sensitized Patients
A growing number of patients on the kidney transplant waiting list are broadly human leukocyte antigen (HLA) sensitized (HS). These patients are unlikely to have a compatible donor.
- Trial name
- NCT01911546
- Testing
- everolimus + low-dose tacrolimus
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Joseph Kahwaji, MD, MPH
Kidney Failure, Chronic, Kidney Transplantation
Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)
The purpose of this clinical trial is to evaluate whether a temporary reprogramming of the immune system can help highly sensitized (hyperimmunized) patients with end-stage kidney disease safely receive a compatible kidney…
- Conditions
- Kidney Failure, Chronic, Kidney Transplantation, Alloimmunization, HLA Sensitization
- Trial name
- HIPER-RESET (NCT07607197)
- Testing
- Autologous Hematopoietic Stem Cell Transplantation
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Highly Sensitized Patients on Waiting List for Kidney Transplantation
Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor
Viela Bio is conducting an open-label, randomized study of inebilizumab, VIB4920, or the combination as part of a multi-center study in highly sensitized patients on the deceased donor waiting list for kidney transplantation.
- Trial name
- NCT04174677
- Testing
- Inebilizumab, VIB4920, Inebilzumab+VIB4920
- Where
- 2 sites in United States
- Sponsor
- Amgen
Chronic Kidney Disease (CKD)
A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)
The purpose of this study is to determine whether vonsetamig will safely decrease anti-HLA antibodies to allow for kidney transplantation.
- Trial name
- NCT05092347
- Testing
- Vonsetamig
- Where
- 10 sites in United States
- Volunteers
- 43 people
- Sponsor
- Regeneron Pharmaceuticals