Not Yet RecruitingPhase 2

VEL-101 to Prevent Rejection After Kidney Transplantation

120 participantsStarted 2026-07

Plain-language summary

This study will evaluate the safety and efficacy of VEL-101 compared with tacrolimus in patients undergoing kidney transplantation.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Receiving kidney allograft from deceased donor or non-human leukocyte antigen (HLA) identical living donor.
✓. Able \& willing to comply with all study procedures, including PK and PD assessments, as assessed by the Investigator
✓. Vaccination up to date per the center's SOC as assessed by the Investigator.
✓. In the opinion of the Investigator, is able to adhere to the study requirements.

Exclusion criteria

✕. 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
✕. Anticipated cold ischemia time (CIT) \>30 hours
✕. Donor with Kidney Donor Profile Index (KDPI) \> 85%
✕. Panel reactive antibody \>80%, calculated panel-reactive antibody (CPRA)\>80% or history of HLA desensitization
✕. Positive T or B cell flow, cytotoxic, or virtual crossmatch at Screening

What they're measuring

Incidence of serious adverse events (SAEs)

Timeframe: Month 12

Incidence of treatment emergent adverse events (TEAEs)

Timeframe: Month 12

PK Parameter Cmax

Timeframe: Day 1, Month 3

PK Parameter Cmin

Timeframe: Day 1, Month 3

PK Parameter Tmax

Timeframe: Day 1, Month 3

AUC from 0-8 hours

Timeframe: Day 1, Month 3

AUC from 0 to 48 hours

Timeframe: Day 2

VEL-101 Accumulation Ratio

Timeframe: Month 3

VEL-101 Pre-Dose Serum Concentration

Timeframe: Day 1, Day 14, Months 1, 2, 3, 6, 9, 12, Periprocedural (kidney biospy)

Trial details

NCT IDNCT07290777

SponsorVeloxis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10

Contact for this trial

Study Director

844-835-6947 or 1-984-309-4040 medinfo@veloxis.com

View on ClinicalTrials.gov More Transplantation, Kidney trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Receiving kidney allograft from deceased donor or non-human leukocyte antigen (HLA) identical living donor.
✓. Able \& willing to comply with all study procedures, including PK and PD assessments, as assessed by the Investigator
✓. Vaccination up to date per the center's SOC as assessed by the Investigator.
✓. In the opinion of the Investigator, is able to adhere to the study requirements.

Exclusion criteria

✕. 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
✕. Anticipated cold ischemia time (CIT) \>30 hours
✕. Donor with Kidney Donor Profile Index (KDPI) \> 85%
✕. Panel reactive antibody \>80%, calculated panel-reactive antibody (CPRA)\>80% or history of HLA desensitization
✕. Positive T or B cell flow, cytotoxic, or virtual crossmatch at Screening

What they're measuring

Incidence of serious adverse events (SAEs)

Timeframe: Month 12

Incidence of treatment emergent adverse events (TEAEs)

Timeframe: Month 12

PK Parameter Cmax

Timeframe: Day 1, Month 3

PK Parameter Cmin

Timeframe: Day 1, Month 3

PK Parameter Tmax

Timeframe: Day 1, Month 3

AUC from 0-8 hours

Timeframe: Day 1, Month 3

AUC from 0 to 48 hours

Timeframe: Day 2

VEL-101 Accumulation Ratio

Timeframe: Month 3

VEL-101 Pre-Dose Serum Concentration

Timeframe: Day 1, Day 14, Months 1, 2, 3, 6, 9, 12, Periprocedural (kidney biospy)