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New treatment option for Renal Transplant Rejection
Official title Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor
ClinicalTrials.gov ID: NCT03707262
What this study is testing
What is Donor CD34+ and CD3+ cells?
Donor CD34+ and CD3+ cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for renal transplant rejection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out if an investigational treatment will allow kidney transplant recipients to better accept their new kidney and stop immunosuppressive medicines. This study is for kidney transplant recipients who receive a kidney from a sibling donor.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Recipient
- Males and females ages 18 years and older receiving living donor kidney transplant from an HLA-identical sibling at UCLA Medical Center.
- Agrees to participate in the study and is able to give informed consent.
- 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...
- Meets institutional criteria for kidney and HSPC transplant.
You likely can't join if
- Donor is identical twin.
- ABO incompatibility with donor.
- Previous solid organ transplant
- Multi-organ transplantation
- Previous treatment with rATG or a known allergy to rabbit proteins
- History of active malignancy within the past 5 years with the exception of non-melanomatous skin cancer. a. History of another primary malignancy...
See the full eligibility criteria
Who can join
- Recipient
- Males and females ages 18 years and older receiving living donor kidney transplant from an HLA-identical sibling at UCLA Medical Center.
- Agrees to participate in the study and is able to give informed consent.
- 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.
- Meets institutional criteria for kidney and HSPC transplant.
- No known contraindication to administration of rATG or radiation.
- If patient is a female of reproductive potential (i.e., no documented absence of ovaries or uterus, history of tubal ligation, or post-menopausal status) patient must be confirmed not pregnant by a serum or urine...
- Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 40% by MUGA (Multi Gated Acquisition) scan or echocardiogram.
- Adequate pulmonary function defined as FVC and DLCO of greater than or equal to 50% of predicted.
- 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 renal transplant team licensed clinical social worker. Recipient
What rules you out
- Donor is identical twin.
- ABO incompatibility with donor.
- Previous solid organ transplant
- Multi-organ transplantation
- Previous treatment with rATG or a known allergy to rabbit proteins
- History of active malignancy within the past 5 years with the exception of non-melanomatous skin cancer. a. History of another primary malignancy except for: i. Malignancy treated with curative intent and with no known...
- 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 \< 100,000/ µL).
- Active bacterial, fungal, mycobacterial or viral infection (including active hepatitis B and/or C).
- Positive HLA DSA
- Seropositivity for HIV 1, HIV 2, HTLVI, HTLV II
- Active West Nile Virus infection
- 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 patient as high risk for non-compliance with the safety monitoring requirements of the study.
- May not have received other immunosuppressive medications, including but not limited to alemtuzumab, belatacept, sirlolimus, everolimus, azathioprine, basiliximab, and eculizumab within six months of the study...
- 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...
- Current or active abuse of alcohol and/or drugs within last 6 months.
- BMI 40 or greater. Donor Inclusion Criteria:
- HLA-identical sibling on high-resolution HLA typing who is ≥18 years of age.
- Meets institutional criteria for living kidney and allogeneic HSPC transplant donation.
- Medically fit to tolerate peripheral blood apheresis, including weighing ≥110 pounds, hemoglobin ≥ 11 g/dL, white blood cell count ≥ 3,000/µL, and platelets ≥120,000/µL.
- Normal serum chemistry and coagulation studies; or, if abnormal, the differences are not considered clinically significant. Donor Exclusion Criteria:
- Recipient is identical twin.
- ABO incompatibility with recipient.
- Medically unfit to tolerate peripheral blood apheresis (small body size, poor vascular access, not a suitable candidate for placement of a central catheter, etc.).
- Pregnant (confirmed by urine or serum pregnancy test) or lactating.
- Seropositivity for HIV 1, HIV 2, HTLV I, HTLV II
- 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:Adequately managed malignancy within the past two years with low risk of recurrence may be acceptable as per clinician discretion
- Adequately managed non-melanoma skin cancer
- Adequately managed carcinoma in situ e.g., cervical cancer in situ, and DCIS
- No current or recent use of oral anti-coagulants. (For the purpose of this study, recent is defined as less than 60 days prior to apheresis.). Note: Use of aspirin and non-steroidal anti-inflammatory drugs, for pain and...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.