Transplantation, KidneyPhase 2RENGEVITY-201NCT07290777
VEL-101 to Prevent Rejection After Kidney Transplantation
A Phase 2 study testing Tacrolimus (TAC) and VEL-101 in people with Transplantation, Kidney, run by Veloxis Pharmaceuticals at 1 site in United States.
Trial summary
This study will evaluate the safety and efficacy of VEL-101 compared with tacrolimus in patients undergoing kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation, Kidney
- What is being tested?
- Tacrolimus (TAC) and VEL-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2026to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Repeat kidney transplant allowed if no previous kidney transplant(s) failed due to recurrent disease within first year, acute rejection or nonsurgical thrombosis
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- 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.
Who cannot join
- 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%
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- 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
- History of malignancy within the past 5 years (with the exception of non-metastatic basal or squamous cell carcinoma of the skin with successful treatment), or current active malignancy
- Liver disease, defined as having elevated aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels greater than three times the upper value of the normal range of the study center at Screening
- Medical condition requiring chronic use of daily prednisone doses >5 mg (or equivalent)
- End-stage renal disease caused by primary focal segmental glomerulosclerosis (FSGS), atypical hemolytic uremic syndrome (aHUS), C3 glomerulopathy, or monoclonal gammopathy of kidney significance
- Note: participants with an unknown cause of ESRD can be included.
- Participation in an investigational study within 30 days or within 5 half-lives of the investigational agent, whichever is longer, prior to Screening
- Receiving any antibody or biologic medicinal product (with the exception of erythropoietin products) within 90 days prior to Screening
- Positive test for SARS-CoV-2 antigen, polymerase chain reaction (PCR), or equivalent testing, at Screening, if performed
- History or presence of coagulopathy, thrombophilia, unexplained bleeding or clotting disorders, or use of systemic anticoagulants at the time of transplant, with the exception of uremic coagulopathy or prophylactic heparin preparations.
- History or presence, upon clinical evaluation, of any illness or condition that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the participant at undue risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
USA Site #1087
Dallas, Texas, 75390
About this study
Official title: A Phase 2, Randomized, Partially Blinded, Controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of VEL-101 in Kidney Transplant Recipients.
This study will evaluate the safety and efficacy of VEL-101 compared with tacrolimus in patients undergoing kidney transplantation.
Read the detailed description
This study is a randomized, multicenter, partially blinded, active control study to evaluate the safety and effectiveness of VEL-101 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1:1 to receive either VEL-101 (low dose or high dose) or tacrolimus.
- Conditions
- Transplantation, Kidney
- Being tested
- Tacrolimus (TAC), VEL-101
- Keywords
- Kidney transplant, VEL-101, pegrizeprument, renal allograft rejection, prophylaxis, kidney, renal, transplant, CD28 inhibitor, monoclonal antibody fragment, FR-104, Anti-CD28
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus (TAC)Drug
Tacrolimus Immediate Release in addition to SOC
VEL-101Drug
Also called Pegrizeprument, FR104
VEL-101 in addition to SOC
| Study group | Role | What they receive |
|---|---|---|
| VEL-101 Low Dose | Experimental | VEL-101 Low Dose Receives: Drug: VEL-101 |
| VEL-101 High Dose | Experimental | VEL-101 High Dose Receives: Drug: VEL-101 |
| Tacrolimus | Active comparator | Tacrolimus Receives: Drug: Tacrolimus (TAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs)
Measured: Month 12
Incidence of treatment emergent adverse events (TEAEs)
Incidence of treatment emergent adverse events (TEAEs)
Measured: Month 12
PK Parameter Cmax
PK Parameter Cmax
Measured: Day 1, Month 3
PK Parameter Cmin
PK Parameter Cmin
Measured: Day 1, Month 3
PK Parameter Tmax
PK Parameter Tmax
Measured: Day 1, Month 3
AUC from 0-8 hours
AUC from 0-8 hours
Measured: Day 1, Month 3
AUC from 0 to 48 hours
AUC from 0 to 48 hours
Measured: Day 2
VEL-101 Accumulation Ratio
VEL-101 Accumulation Ratio
Measured: Month 3
VEL-101 Pre-Dose Serum Concentration
VEL-101 Pre-Dose Serum Concentration
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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
Death, graft failure or biopsy proven acute rejection (BPAR, T cell mediated rejection [TCMR] Banff Grade > or = to 1A or antibody-mediated rejection [AMR] )
Measured: Month 12
Slope of estimated glomerular filtration rage (eGFR)
Slope of estimated glomerular filtration rage (eGFR)
Measured: Month 12
Incidence Injection Site Reaction
Incidence Injection Site Reaction
Measured: Month 12
Incidence Adverse Events of Special Interest (AESIs)
AESIs Including BK viremia, BK virus-associate nephropathy, EBV viremia, PTLD, CMV viremia, CMV disease, malignancies
Measured: Month 12
Proportion of Participants Discontinuing due to Adverse Events
Proportion of Participants Discontinuing due to Adverse Events
Measured: Month 12
Incidence Delayed Graft Function Delayed Graft Function
Incidence Delayed Graft Function
Measured: Day 28
Duration Delayed Graft Function
Duration Delayed Graft Function
Measured: Day 28
Incidence of Renal Replacement Therapy (RRT)
Incidence of Renal Replacement Therapy (RRT)
Measured: Month 12
Duration of Renal Replacement Therapy (RRT)
Duration of Renal Replacement Therapy (RRT)
Measured: Month 12
Incidence of New-Onset Diabetes after Transplantation (NODAT)
Incidence of New-Onset Diabetes after Transplantation (NODAT)
Measured: Month 12
Effect of Anti-Drug Antibody (ADA) Formation on VEL-101 t1/2 (hours)
Effect of Anti-Drug Antibody (ADA) Formation on VEL-101 t1/2 (hours)
Measured: Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)
Effect of Anti-Drug Antibody (ADA) Development on VEL-101 Volume of distribution (liters)
Effect of Anti-Drug Antibody (ADA) Development on VEL-101 Volume of distribution (liters)
Measured: Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)
Effect of Anti-Drug Antibody Development on VEL-101 Cmin (ng/mL)
Effect of Anti-Drug Antibody Development on VEL-101 Cmin (ng/mL)
Measured: Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)
Effect of Anti-Drug Antibody Development on VEL-101 Cmax (ng/mL)
Effect of Anti-Drug Antibody Development on VEL-101 Cmax (ng/mL)
Measured: Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start18 Aug 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation, KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veloxis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290777
- Sponsor's protocol ID
- VEL-101.KI201
- Acronym
- RENGEVITY-201
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Partially Blinded, Controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of VEL-101 in Kidney Transplant Recipients.
- ClinicalTrials.gov ID
- NCT07290777
- Acronym / sponsor ID
- RENGEVITY-201 / VEL-101.KI201
- Conditions
- Transplantation, Kidney
- Keywords
- Kidney transplant, VEL-101, pegrizeprument, renal allograft rejection, prophylaxis, kidney, renal, transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Veloxis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of VEL-101 compared with tacrolimus in patients undergoing kidney transplantation.
Detailed description
This study is a randomized, multicenter, partially blinded, active control study to evaluate the safety and effectiveness of VEL-101 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1:1 to receive either VEL-101 (low dose or high dose) or tacrolimus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VEL-101 Low Dose | Experimental | Drug: VEL-101VEL-101 Low Dose |
| VEL-101 High Dose | Experimental | Drug: VEL-101VEL-101 High Dose |
| Tacrolimus | Active comparator | Drug: Tacrolimus (TAC)Tacrolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus (TAC)Tacrolimus Immediate Release in addition to SOC | Drug | Tacrolimus |
| VEL-101Also: Pegrizeprument, FR104VEL-101 in addition to SOC | Drug | VEL-101 High Dose, VEL-101 Low Dose |
Primary outcome
Incidence of serious adverse events (SAEs)
Time frame: Month 12
Incidence of serious adverse events (SAEs)
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Month 12
Incidence of treatment emergent adverse events (TEAEs)
PK Parameter Cmax
Time frame: Day 1, Month 3
PK Parameter Cmax
PK Parameter Cmin
Time frame: Day 1, Month 3
PK Parameter Cmin
PK Parameter Tmax
Time frame: Day 1, Month 3
PK Parameter Tmax
AUC from 0-8 hours
Time frame: Day 1, Month 3
AUC from 0-8 hours
AUC from 0 to 48 hours
Time frame: Day 2
AUC from 0 to 48 hours
VEL-101 Accumulation Ratio
Time frame: Month 3
VEL-101 Accumulation Ratio
VEL-101 Pre-Dose Serum Concentration
Time frame: Day 1, Day 14, Months 1, 2, 3, 6, 9, 12, Periprocedural (kidney biospy)
VEL-101 Pre-Dose Serum Concentration
Effect of Anti-Drug Antibody (ADA) Development on VEL-101 Serum Concentration
Time frame: Months 1, 2, 3, 6, 9, 12, Periprocedural (kidney biopsy)
Effect of Anti-Drug Antibody (ADA) Development on VEL-101 Serum Concentration
Effect of Neutralizing Antibody (NAb) Development on VEL-101 Serum Concentration
Time frame: Day 1, Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)
Effect of Neutralizing Antibody (NAb) Development on VEL-101 Serum Concentration
VEL-101 CD28 Receptor Occupancy Concentration (%)
Time frame: 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)
VEL-101 CD28 Receptor Occupancy Concentration (%)
14 secondary outcomes
Percentage Participants Meeting Composite Endpoint
Time frame: Month 12
Slope of estimated glomerular filtration rage (eGFR)
Time frame: Month 12
Incidence Injection Site Reaction
Time frame: Month 12
Incidence Adverse Events of Special Interest (AESIs)
Time frame: Month 12
Proportion of Participants Discontinuing due to Adverse Events
Time frame: Month 12
Incidence Delayed Graft Function Delayed Graft Function
Time frame: Day 28
Duration Delayed Graft Function
Time frame: Day 28
Incidence of Renal Replacement Therapy (RRT)
Time frame: Month 12
Duration of Renal Replacement Therapy (RRT)
Time frame: Month 12
Incidence of New-Onset Diabetes after Transplantation (NODAT)
Time frame: Month 12
Effect of Anti-Drug Antibody (ADA) Formation on VEL-101 t1/2 (hours)
Time frame: Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)
Effect of Anti-Drug Antibody (ADA) Development on VEL-101 Volume of distribution (liters)
Time frame: Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)
Effect of Anti-Drug Antibody Development on VEL-101 Cmin (ng/mL)
Time frame: Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)
Effect of Anti-Drug Antibody Development on VEL-101 Cmax (ng/mL)
Time frame: Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tacrolimus (TAC) and VEL-101 in people with Transplantation, Kidney, run by Veloxis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (844-835-6947 or 1-984-309-4040, medinfo@veloxis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (SAEs) (time frame: Month 12). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.