Kidney Failure Chronic study: Venetoclax vs Kidney Transplant
Official title Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
ClinicalTrials.gov ID: NCT07358195
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for kidney failure chronic.
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
- This study is testing whether adding venetoclax to the transplant process is safe and does not cause severe side effects.
- Who it's for
- You may be able to join if you have chronic kidney failure and are planned for a combined stem‑cell and kidney transplant.
- What's involved
- You would take venetoclax tablets before and after the transplant. You will have the transplant as usual and attend regular check‑ups to monitor your health.
- Time commitment
- The study lasts several months and includes multiple clinic visits after the transplant to check safety.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Recipient
- Patient ages 18-70
- Underlying hematological malignancy which is deemed as being potentially curable with allogeneic bone marrow or PBSC transplantation by the BMT...
- Hematological malignancies include, but are not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous...
- Existence of an HLA-matched or haploidentical relative who passes standard donor evaluations for bone marrow and kidney donation
You likely can't join if
- Active serious infection
- Participation in other investigational drug use at the time of enrollment
- Positivity for active infection with HIV, HCV, or HBV
- ABO blood group incompatibility in the host-vs-graft direction
See the full eligibility criteria
- Recipient
- Patient ages 18-70
- Underlying hematological malignancy which is deemed as being potentially curable with allogeneic bone marrow or PBSC transplantation by the BMT voting team.
- Hematological malignancies include, but are not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma...
- Existence of an HLA-matched or haploidentical relative who passes standard donor evaluations for bone marrow and kidney donation
- LVEF \> 40% as measured by echocardiography or MUGA
- FEV1, FVC, and DLCO \> 50% of predicted as measured by standard PFTs
- Total bilirubin \< 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all \< 5x institutions upper limit of normal
- ABO compatibility in the host vs. graft direction
- Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 1 year following the transplant.
- Participants should be on dialysis or have a CrCl ≤ 35 ml/min
- Life expectancy greater than 6 months
- Recipient ability to understand and provide informed consent Donor
- HLA matched or haploidentical relative as defined by 3/6, 4/6, or 5/6 HLA-matched at HLA -A, -B, or -DRB1 who is 18-70 years of age
- ECOG performance status 0 or 1
- Excellent health per conventional pre-donor history (medical and psychosocial evaluation)
- Acceptable laboratory parameters (hematology in normal or near-normal range; liver function \< 3 times the upper limit of normal and normal creatinine)
- Compatible ABO blood group
- Negative donor lymphocyte cross match
- No positive testing for active viral infection (Hepatitis B, Hepatitis C, HIV)
- Donor ability to understand and provide informed consent
- Meets standard institutional criteria for both bone marrow or peripheral blood stem cell (PBSC) and kidney donation
- Active serious infection
- Participation in other investigational drug use at the time of enrollment
- Positivity for active infection with HIV, HCV, or HBV
- ABO blood group incompatibility in the host-vs-graft direction
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, 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, but 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.