Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation
NCT ID: NCT02417870
Last Updated: 2021-06-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
2 participants
INTERVENTIONAL
2015-09-30
2018-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Desensitization Protocols in HLA-incompatible Kidney-transplant Candidates
NCT03507348
Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients
NCT00306397
Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies
NCT00307125
Eculizumab Therapy for Subclinical Antibody-mediated Rejection in Kidney Transplantation
NCT02113891
Rituximab Treatment to Block HLA Antibodies in Renal Transplant Recipients
NCT00261547
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
aldesleukin
aldesleukin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
aldesleukin
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \>18 years and \<75 years of age
* \>6 months post Tx
* on stable dose of immunosuppression
* Transplant biopsy showing interstitial fibrosis and tubular atrophy of grade II or greater, with some evidence of lymphocytic infiltration (biopsy is NOT a study procedure, it would be performed as part of the patient's SOC)
* Ability to give informed consent
Exclusion Criteria
* Baseline creatinine \>3.5mg/dL
* Patients with active infection, including Hepatitis B and C, HIV
* Current or prior invasive malignancy
* Patients who are pregnant or breastfeeding
* Patients who are unable to give consent
* Prior intolerance of/allergy to IL2
* Inability to comply with treatment
* History of thrombotic angiopathy including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura
* Symptomatic congestive cardiac failure or uncontrolled cardiac angina
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
* WOCBP and male subjects with reproductive potential must agree to use a highly effective method of birth control \[defined in protocol \& ICF\] during study treatment, and for 6 months after completion of treatment.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Anil K. Chandraker, MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Anil K. Chandraker, MD
Medical Director of Kidney and Pancreas Transplantation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anil Chandraker
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015P000796
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.