临床试验/NCT07290777

NCT07290777招募中2 期

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.

Veloxis Pharmaceuticals1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2026年8月18日最近更新: 2026年9月3日

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 120
试验地点: 1
主要终点: Incidence of serious adverse events (SAEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double (Participant, Investigator)

盲法说明

Investigator/participant blinded to VEL-101 dose level but not blinded to participants receiving tacrolimus.

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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
•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
•a) 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.

研究组 & 干预措施

VEL-101 Low Dose

Experimental

VEL-101 Low Dose

干预措施: VEL-101 (Drug)

VEL-101 High Dose

Experimental

VEL-101 High Dose

干预措施: VEL-101 (Drug)

Tacrolimus

Active Comparator

Tacrolimus

干预措施: Tacrolimus (TAC) (Drug)

结局指标

主要结局

Incidence of serious adverse events (SAEs)

时间窗: Month 12

Incidence of serious adverse events (SAEs)

Incidence of treatment emergent adverse events (TEAEs)

时间窗: Month 12

Incidence of treatment emergent adverse events (TEAEs)

PK Parameter Cmax

时间窗: Day 1, Month 3

PK Parameter Cmax

PK Parameter Cmin

时间窗: Day 1, Month 3

PK Parameter Cmin

PK Parameter Tmax

时间窗: Day 1, Month 3

PK Parameter Tmax

AUC from 0-8 hours

时间窗: Day 1, Month 3

AUC from 0-8 hours

AUC from 0 to 48 hours

时间窗: Day 2

AUC from 0 to 48 hours

VEL-101 Accumulation Ratio

时间窗: Month 3

VEL-101 Accumulation Ratio

VEL-101 Pre-Dose Serum Concentration

时间窗: 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

时间窗: 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

时间窗: 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 (%)

时间窗: 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 (%)

次要结局

Duration of Renal Replacement Therapy (RRT)(Month 12)
Incidence of New-Onset Diabetes after Transplantation (NODAT)(Month 12)
Effect of Anti-Drug Antibody (ADA) Formation on VEL-101 t1/2 (hours)(Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy))
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)
Incidence Delayed Graft Function Delayed Graft Function(Day 28)
Duration Delayed Graft Function(Day 28)
Incidence of Renal Replacement Therapy (RRT)(Month 12)
Effect of Anti-Drug Antibody (ADA) Development on VEL-101 Volume of distribution (liters)(Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy))
Effect of Anti-Drug Antibody Development on VEL-101 Cmin (ng/mL)(Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy))
Effect of Anti-Drug Antibody Development on VEL-101 Cmax (ng/mL)(Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy))

研究者

发起方

Veloxis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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