Is NCT05525507 recruiting in Los Angeles, CA?

Yes, NCT05525507 is currently recruiting participants at its Los Angeles, CA location. This end stage kidney disease clinical trial is actively enrolling qualified participants.

How do I join the end stage kidney disease clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, 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 Los Angeles 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.

End Stage Kidney Disease Clinical Trial in Los Angeles, CA

About This End Stage Kidney Disease Study in Los Angeles

The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG).

Sponsor: University of California, Los Angeles

Who Can Participate

Inclusion Criteria

Males and females ages 18 years and older with a pre- existing kidney transplant from an HLA-matched living donor.

Pre-existing living kidney transplant must be within 3 months to 5 years from date of scheduled HPSC infusion.

No history of rejection with current HLA matched kidney transplant.

Recipient is without post-transplant major complications, including de novo malignancy, active infection or rejection.

Stable renal function determined per investigator discretion.

Agreement to participate in the study and ability to give informed consent.

Meets institutional criteria for HSPC infusion.

Resides or is willing to stay within 3 hours distance from UCLA Medical Center by ground transportation for the first three to six months of the trial at the physician's discretion.

No known contraindication to administration of rATG or radiation.

If participant is a female of reproductive potential (i.e., no documented absence of ovaries or uterus, history of tubal ligation, or post-menopausal status) participant must be confirmed not pregnant by a serum or urine pregnancy test) and must agree to practice a reliable form of contraception including hormonal treatments, barrier methods or intrauterine device for at least 12 months post-transplant.

Karnofsky Performance Score (KPS) ≥ 70.

Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 40% by MUGA (Multi Gated Acquisition) scan or echocardiogram.

Adequate liver function defined as total bilirubin ≤ 1.5 times the upper limit of normal and AST/ALT ≤ 2.0 times the upper limit of normal.

Adequate social support based on evaluation by the UCLA bone marrow and/or renal transplant team. Recipient

Exclusion Criteria

Donor is identical twin.

Major ABO incompatibility with donor

Positive HLA Donor-Specific Antibody (DSA)

History of multi-organ transplantation

History of rejection with current HLA-matched kidney transplant

Known allergy to rabbit proteins

History of post-transplant major complications, including de novo malignancy, active/chronic infection or rejection, with the exception of low risk, early-stage malignancy with ≥90% 5-year survival not receiving chemotherapy or immunotherapy and non-melanomatous skin cancer.

History of active malignancy within the past 5 years with the exception:

Low risk cancer on active surveillance

Malignancy treated with curative intent with no known active disease \>2 years before the first dose of study treatment and of low potential risk for recurrence

Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease

Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, and DCIS)

Worsening renal functioning over preceding 3-month interval determined per investigator discretion.

Pregnant (confirmed by urine or serum pregnancy test) or lactating.

Leukopenia (with a white blood cell count \< 3,000/µL) or thrombocytopenia (with a platelet count \< 70,000/µL).

EBV, CMV and BK PCR negative at time of HPSC infusion is preferred, but if they have had a history of + CMV/BK PCR, it should be resolved by 3 months.

Active bacterial, fungal, mycobacterial, or viral infection (including active hepatitis B and/or C).

Seropositivity for HIV 1 or 2 by 4th generation serum antibody/antigen testing, or HTLV I or II by serum antibody testing.

Renal disease with high risk of recurrence (i.e., focal segmental glomerulosclerosis).

Advanced hepatic fibrosis or cirrhosis secondary to hepatitis B and/or C diagnosis.

Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; active extra-renal autoimmune disease requiring immunosuppression.

Active extra-renal autoimmune disease requiring immunosuppression.

Neuropsychiatric illness that precludes the ability to give informed consent and/or places the participant as high risk for non-compliance with the safety monitoring requirements of the study.

May not have received other immunomodulatory agents, including but not limited to tumor necrosis factor inhibitors within six months of the study treatment. Use of corticosteroids prescribed for a time-limited indication (\</= 4 weeks) and stopped at least 4 weeks before the kidney transplant is acceptable.

May not have received immunotherapy drugs such as immune checkpoint inhibitors (e.g. pembrolizumab, nivolumab, and ipilimumab), tumor necrosis factor inhibitors, rituximab, and interleukin-2 within six months of the study treatment.

Current or active abuse of alcohol and/or drugs within last 6 months.

Body Mass Index (BMI) ≥ 40. Donor Inclusion Criteria:

HLA-matched sibling on high-resolution HLA typing who a. is ≥18 years of age.

Must meet institutional criteria for HSPC transplant donation.

Medically fit to tolerate peripheral blood apheresis, including weighing ≥110 pounds, hemoglobin ≥11, white blood cell count ≥ 3,000/µL, and platelets ≥ 100,000/µL.

Serum creatinine as expected post-kidney donation and coagulation parameter studies; or, if abnormal, the changes are not considered clinically significant. Donor exclusion criteria:

Recipient is identical twin.

Major ABO incompatibility with recipient.

Medically unfit to tolerate peripheral blood apheresis (e.g. small body size, poor vascular access, not a suitable candidate for placement of a central catheter).

Pregnant (confirmed by urine or serum pregnancy test) or lactating.

Seropositivity for HIV 1 or 2 by 4th generation serum antibody/antigen testing, HTLV I or II by serum antibody testing

Active West Nile Virus infection.

Active bacterial, fungal, mycobacterial or viral infection (including active hepatitis B and/or C).

Psychiatric, addictive, neurological, or other disorder that compromises ability to give true informed consent for participation in this study.

History of active malignancy within the past 5 years with the exception:

Low risk cancer on active surveillance

Malignancy treated with curative intent with no known active disease \>2 years before the first dose of study treatment and of low potential risk for recurrence

Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease

Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, and DCIS)

No use of oral anticoagulants 2 days prior to apheresis. Note: Use of aspirin and non-steroidal anti-inflammatory drugs, for pain and inflammation management purposes, are permitted to enroll in the study, but these drugs must be stopped 7 days prior to apheresis, however subjects who are taking aspirin for its anti- platelet/anti-thrombotic effect, are excluded.

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 Los Angeles?

Yes, this clinical trial (NCT05525507) has an active research site in Los Angeles, CA 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.

End Stage Kidney Disease Treatment Options in Los Angeles, CA

If you're searching for end stage kidney disease treatment options in Los Angeles, CA, this clinical trial (NCT05525507) 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 Los Angeles research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced end stage kidney disease 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 end stage kidney disease clinical trials near you to find additional studies recruiting in your area.

End Stage Kidney Disease Clinical Trial in Los Angeles, CA

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