VEL-101 to Prevent Rejection After Kidney Transplantation
ConditionTransplantation, Kidney
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVeloxis Pharmaceuticals
About this trial
This study will evaluate the safety and efficacy of VEL-101 compared with tacrolimus in patients undergoing kidney transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Greater than or equal to 18 years of age
Able to understand key components of the study as described in the written informed consent document and willing and able to provide written informed consent.
If female, surgically sterile (post hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), postmenopausal (greater than 12 months of amenorrhea without alternative medical causes), or, if of childbearing potential, is using a highly effective contraception until 90 days after EOS visit.
If male, is vasectomized, has undergone bilateral orchidectomy, agrees to abstinence of heterosexual intercourse, or only has female partner using highly effective contraception, surgically sterile or postmenopausal and agrees to use method until 90 days after EOS visit.
Disqualifiers
Negative for EBV or Epstein-Barr nuclear antigen antibody
Know allergy to study medication (rATG, corticosteroids, MMF, tacrolimus, or VEL-101) or its components or a history of a severe allergic reaction to any drug.
History of previous non-kidney solid organ, vascular composite allograft, pancreatic islet, stem cell or bone marrow transplant.
Planned multiorgan transplant, including dual or en-bloc kidney transplant
Trial design
Design model
Parallel
Treatments tested in this trial
Tacrolimus (TAC)
DrugTacrolimus Immediate Release in addition to SOC
VEL-101
DrugVEL-101 in addition to SOC
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: VEL-101 Low DoseExperimental treatment 1 intervention
Group B: VEL-101 High DoseExperimental treatment 1 intervention
Group C: TacrolimusActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs)
Time frame
Month 122
Incidence of treatment emergent adverse events (TEAEs)
Incidence of treatment emergent adverse events (TEAEs)
Time frame
Month 123
PK Parameter Cmax
PK Parameter Cmax
Time frame
Day 1, Month 34
PK Parameter Cmin
PK Parameter Cmin
Time frame
Day 1, Month 3Secondary outcomes
1
Percentage Participants Meeting Composite Endpoint
Death, graft failure or biopsy proven acute rejection (BPAR, T cell mediated rejection \[TCMR\] Banff Grade \> or = to 1A or antibody-mediated rejection \[AMR\] )
Time frame
Month 122
Slope of estimated glomerular filtration rage (eGFR)
Slope of estimated glomerular filtration rage (eGFR)
Time frame
Month 123
Incidence Injection Site Reaction
Incidence Injection Site Reaction
Time frame
Month 124
Incidence Adverse Events of Special Interest (AESIs)
AESIs Including BK viremia, BK virus-associate nephropathy, EBV viremia, PTLD, CMV viremia, CMV disease, malignancies
Time frame
Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov