VEL-101 to Prevent Rejection After Kidney Transplantation

NCT07290777 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: VEL-101.KI201
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Transplantation, Kidney

Keywords

Kidney transplant; VEL-101; pegrizeprument; renal allograft rejection; prophylaxis; kidney; renal; transplant; CD28 inhibitor; monoclonal antibody fragment; FR-104; Anti-CD28

Outcome Measures

Primary Outcomes (12)

• Incidence of serious adverse events (SAEs)

  Incidence of serious adverse events (SAEs)

  Month 12

• Incidence of treatment emergent adverse events (TEAEs)

  Incidence of treatment emergent adverse events (TEAEs)

  Month 12

• PK Parameter Cmax

  PK Parameter Cmax

  Day 1, Month 3

• PK Parameter Cmin

  PK Parameter Cmin

  Day 1, Month 3

• PK Parameter Tmax

  PK Parameter Tmax

  Day 1, Month 3

• AUC from 0-8 hours

  AUC from 0-8 hours

  Day 1, Month 3

• AUC from 0 to 48 hours

  AUC from 0 to 48 hours

  Day 2

• VEL-101 Accumulation Ratio

  VEL-101 Accumulation Ratio

  Month 3

• VEL-101 Pre-Dose Serum Concentration

  VEL-101 Pre-Dose Serum Concentration

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

• Effect of Anti-Drug Antibody (ADA) Development on VEL-101 Serum Concentration

  Effect of Anti-Drug Antibody (ADA) Development on VEL-101 Serum Concentration

  Months 1, 2, 3, 6, 9, 12, Periprocedural (kidney biopsy)

• Effect of Neutralizing Antibody (NAb) Development on VEL-101 Serum Concentration

  Effect of Neutralizing Antibody (NAb) Development on VEL-101 Serum Concentration

  Day 1, Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)

• VEL-101 CD28 Receptor Occupancy Concentration (%)

  VEL-101 CD28 Receptor Occupancy Concentration (%)

  Days 1, 2, 3, 4, 5, 7, 14, 42, 70, 82, 91, 98 and Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)

Secondary Outcomes (14)

• Percentage Participants Meeting Composite Endpoint

  Month 12

• Slope of estimated glomerular filtration rage (eGFR)

  Month 12

• Incidence Injection Site Reaction

  Month 12

• Incidence Adverse Events of Special Interest (AESIs)

  Month 12

• Proportion of Participants Discontinuing due to Adverse Events

  Month 12

Study Arms (3)

VEL-101 Low Dose

EXPERIMENTAL

VEL-101 Low Dose

Drug: VEL-101

VEL-101 High Dose

EXPERIMENTAL

VEL-101 High Dose

Drug: VEL-101

Tacrolimus

ACTIVE COMPARATOR

Tacrolimus

Drug: Tacrolimus (TAC)

Interventions

Tacrolimus (TAC) DRUG

Tacrolimus Immediate Release in addition to SOC

Tacrolimus

VEL-101 DRUG

VEL-101 in addition to SOC

Also known as: Pegrizeprument, FR104

VEL-101 High Dose; VEL-101 Low Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• a) Repeat kidney transplant allowed if no previous kidney transplant(s) failed due to recurrent disease within first year, acute rejection or nonsurgical thrombosis
• 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.

You may not qualify if:

• 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
• Current or historical DSA
• Recipient or donor with positive hepatitis B surface antigen (HBsAG), hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) nucleic acid testing (NAT), hepatitis C virus (HCV) antibody, HCV NAT, human immunodeficiency virus (HIV), or HIV NAT
• Recipient who is CMV IgG negative (R-) receiving a kidney from a donor who is CMV IgG positive (D+)
• Thrombocytopenia (platelets \< 75,00/mm3), leukopenia (white blood cells \[WBC\] \<3,000/mm3), or anemia (hemoglobin \<8 g/dL) at Screening
• History of inadequately treated active or latent mycobacterium tuberculosis (TB) infection
• Clinically significant abnormality on 12-lead electrocardiogram (ECG) at Screening, as determined by the Investigator
• Positive pregnancy test or lactating at Screening with plans to continue lactating regimen throughout the study

Sponsors & Collaborators

• Veloxis Pharmaceuticals: lead

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Central Study Contacts

Study Director

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigator/participant blinded to VEL-101 dose level but not blinded to participants receiving tacrolimus.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 18, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share