Is NCT07290777 recruiting in Dallas, TX?

Yes, NCT07290777 is currently recruiting participants at its Dallas, TX location. This transplantation, kidney clinical trial is actively enrolling qualified participants.

How do I join the transplantation, kidney clinical trial in Dallas?

To join this clinical trial in Dallas, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Dallas clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Transplantation, Kidney Clinical Trial in Dallas, TX

Who Can Participate

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. 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.

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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Dallas?

Yes, this clinical trial (NCT07290777) has an active research site in Dallas, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Transplantation, Kidney Treatment Options in Dallas, TX

If you're searching for transplantation, kidney treatment options in Dallas, TX, this clinical trial (NCT07290777) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Dallas research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced transplantation, kidney specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all transplantation, kidney clinical trials near you to find additional studies recruiting in your area.

Transplantation, Kidney Clinical Trial in Dallas, TX

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