Phase 1 Chronic Kidney Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For the kidney transplant recipient (the patient):

• Adults aged 18 or older who have already received a kidney transplant from a living donor whose tissue type (HLA) closely matches theirs
• The kidney transplant was received between 3 months and 5 years before the planned date of the stem cell infusion used in this trial
• No history of rejection of the current kidney transplant
• No major complications since the transplant, such as new cancers, active infections, or rejection episodes
• Stable kidney function, as determined by the treating doctor
• Willing and able to give informed consent to participate in the study
• Meets the hospital's own internal requirements for receiving a stem cell infusion
• Able to stay within 3 hours' travel (by road) from UCLA Medical Center for the first 3 to 6 months of the trial, as directed by the treating doctor
• No known reasons why the medications rabbit anti-thymocyte globulin (rATG) or radiation treatment could not be given safely (confirm with trial site)
• Women who could potentially become pregnant must have a negative pregnancy test confirmed before joining, and must agree to use a reliable form of contraception (such as hormonal methods, barrier methods, or an intrauterine device) for at least 12 months after the transplant procedure in this trial
• A general health and functioning score (called the Karnofsky Performance Score) of 70 or above, meaning the person is reasonably able to carry out normal activity with some effort (confirm with trial site)
• Adequate heart function, measured by a heart scan showing the heart pumps at least 40% of its blood volume with each beat
• Liver function within acceptable ranges, based on specific blood test results (confirm with trial site for exact values)
• Adequate social support, as assessed by the UCLA bone marrow and/or kidney transplant team

For the stem cell donor (the sibling):

• A brother or sister whose tissue type (HLA) closely matches the recipient's, confirmed by detailed testing, and who is aged 18 or older
• Meets the hospital's own internal requirements for donating stem cells
• Physically well enough to undergo the blood collection procedure (apheresis), including weighing at least 110 pounds and having blood count levels within acceptable ranges (confirm with trial site for exact values)
• Kidney and blood clotting test results that are normal or only slightly outside the normal range in a way the doctor considers not medically significant

Who may not be able to join:

For the kidney transplant recipient (the patient):

• The donor is an identical twin of the recipient
• There is a significant mismatch in blood type (ABO) between the recipient and donor
• Blood tests show the presence of antibodies specifically targeting the donor's tissue (called donor-specific antibodies or DSA)
• The person has had more than one organ transplant
• There has been a rejection episode with the current kidney transplant
• Known allergy to rabbit proteins
• History of major complications after the transplant, including new cancers, ongoing or chronic infections, or rejection — except for certain very early-stage, low-risk cancers with a very high survival rate that are not being treated with chemotherapy or immunotherapy, or certain non-melanoma skin cancers
• A history of active cancer within the past 5 years, with limited exceptions including: certain low-risk cancers being monitored without treatment; cancers treated with the intention to cure, with no known active disease for more than 2 years and a low chance of returning; adequately treated non-melanoma skin cancer or a specific type of skin lesion (lentigo maligna) with no signs of disease remaining; or adequately treated early-stage cancer confined to one area (carcinoma in situ) with no signs of disease remaining (such as early cervical cancer or a specific type of early breast change called DCIS)
• Kidney function that has been getting worse over the 3 months before joining, as determined by the treating doctor
• Currently pregnant (confirmed by a pregnancy test) or breastfeeding
• Abnormally low white blood cell count or low platelet count, based on specific blood test thresholds (confirm with trial site)
• Certain viral markers in the blood at the time of the stem cell infusion that have not resolved (confirm with trial site for details)
• A current active infection, including bacterial, fungal, or viral infections such as active hepatitis B or C
• Testing positive for HIV (types 1 or 2) or HTLV (types I or II)
• A kidney disease that has a high chance of coming back in a transplanted kidney, such as a condition called focal segmental glomerulosclerosis
• Advanced liver scarring or liver failure related to hepatitis B or C
• Serious uncontrolled health conditions, including certain heart conditions (such as heart failure with symptoms, unstable chest pain, or irregular heartbeat) or an active autoimmune disease affecting organs other than the kidneys that requires immune-suppressing treatment
• A mental health or neurological condition that prevents the person from giving informed consent or that the trial team considers to place the person at high risk of not being able to follow the study's safety monitoring requirements
• Having received certain immune-modifying medications — including but not limited to tumour necrosis factor inhibitors — within 6 months before the study treatment (short courses of corticosteroids of 4 weeks or less, stopped at least 4 weeks before the kidney transplant, may be acceptable — confirm with trial site)
• Having received certain immunotherapy drugs — including immune checkpoint inhibitors (such as pembrolizumab, nivolumab, or ipilimumab), rituximab, or interleukin-2 — within 6 months before the study treatment
• Current or recent alcohol or drug misuse within the past 6 months
• A body mass index (BMI) of 40 or above

For the stem cell donor (the sibling):

• The recipient is the donor's identical twin
• There is a significant mismatch in blood type (ABO) between the donor and recipient
• Not physically able to safely undergo the blood collection procedure (apheresis), for example due to small body size, poor vein access, or not being a suitable candidate for a central line catheter
• Currently pregnant (confirmed by a pregnancy test) or breastfeeding
• Testing positive for HIV (types 1 or 2) or HTLV (types I or II)
• Currently has an active West Nile Virus infection
• Currently has an active bacterial, fungal, or viral infection, including active hepatitis B or C
• A psychiatric, addiction-related, neurological, or other condition that prevents the person from giving true informed consent to participate
• A history of active cancer within the past 5 years, with the same limited exceptions listed for recipients above (low-risk cancers under surveillance; cancers treated to cure with no active disease for more than 2 years; adequately treated non-melanoma skin cancer or lentigo maligna; adequately treated carcinoma in situ with no remaining disease)
• Currently taking blood-thinning tablets (oral anticoagulants) — these must be stopped at least 2 days before the blood collection procedure; people taking aspirin specifically to prevent blood clots are not eligible (though aspirin taken for pain or inflammation may be permitted up to 7 days before the procedure — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.