Kidney Failure ChronicEarly Phase 1NCT07358195
Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
A Early Phase 1 study testing Venetoclax, Hematopoietic Cell Transplantation Conditioning Regimen and Kidney Transplant in people with Kidney Failure Chronic and Stem Cell Transplant, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary objective is to assess the safety of the addition of venetoclax to reduced intensity conditioning for HLA-matched and haploidentical combined HSC and kidney transplantation as measured by stable full donor hematopoiesis and absence of CTCAE grade IV or V toxicity attributable to venetoclax. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Failure Chronic, Stem Cell Transplant, Stem Cell Transplant Complications
- What is being tested?
- Venetoclax, Hematopoietic Cell Transplantation Conditioning Regimen and Kidney Transplant
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2026to Dec 2031
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Thomas Spitzer, MD, 617-724-1124, tspitzer@mgh.harvard.edu
About this study
Official title: Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy
The primary objective is to assess the safety of the addition of venetoclax to reduced intensity conditioning for HLA-matched and haploidentical combined HSC and kidney transplantation as measured by stable full donor hematopoiesis and absence of CTCAE grade IV or V toxicity attributable to venetoclax.
- Conditions
- Kidney Failure Chronic, Stem Cell Transplant, Stem Cell Transplant Complications, Tolerance, Hematologic Cancer
- Being tested
- Venetoclax, Hematopoietic Cell Transplantation Conditioning Regimen, Kidney Transplant, Hematopoietic Cell Transplantation
- Medical subject headings
- Renal Insufficiency, Chronic, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Venetoclax 400mg orally once daily on days -8 through -1 with daily monitoring for tumor lysis syndrome. Venetoclax tablets will be swallowed (not crushed). Venetoclax dosing will not be repeated in the event of vomiting.
Hematopoietic Cell Transplantation Conditioning RegimenProcedure or surgery
Cytoxan Day -6 \& -5 Fludarabine Day -4, -3, -2 TBI Day -1
Kidney TransplantProcedure or surgery
Living donor kidney transplant
Hematopoietic Cell TransplantationProcedure or surgery
Donor bone marrow (target of 4 x 108 nucleated cells/kg of recipient ideal body weight)
PBSC A goal dose of 5 x 106 CD34+ cells / kg of recipient actual body weight will be infused (minimum acceptable is 2 x 106 CD34+ cells / kg).
| Study group | Role | What they receive |
|---|---|---|
| Recipient | Experimental | Stem Cell and Kidney Transplant Receives: Drug: Venetoclax; Procedure: Hematopoietic Cell Transplantation Conditioning Regimen; Procedure: Kidney Transplant; Procedure: Hematopoietic Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of full donor chimerism
Measured: 24 months
Incidence of Grade IV Toxicity due to Venetoclax
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Days -8 to Days -1
Incidence of Grade V Toxicity due to Venetoclax
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Days -8 to Days -1
Secondary outcomes (6)
Incidence of acute renal allograft rejection
Measured: 24 months
Incidence of delayed renal allograft rejection
Measured: 24 months
Incidence of acute GVHD
Measured: 24 months
Incidence of Chronic GVHD
Measured: 24 months
Patient Survival Rate
Measured: 24 months
Allograft Survival Rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start4 Feb 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure ChronicStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Spitzer, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358195
- Sponsor's protocol ID
- DFCC 25-668
- Status last verified
- Oct 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT07358195
- Acronym / sponsor ID
- DFCC 25-668
- Conditions
- Kidney Failure Chronic, Stem Cell Transplant, Stem Cell Transplant Complications, Tolerance, Hematologic Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the safety of the addition of venetoclax to reduced intensity conditioning for HLA-matched and haploidentical combined HSC and kidney transplantation as measured by stable full donor hematopoiesis and absence of CTCAE grade IV or V toxicity attributable to venetoclax.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recipient | Experimental | Drug: Venetoclax, Procedure: Hematopoietic Cell Transplantation Conditioning Regimen, Procedure: Kidney Transplant, Procedure: Hematopoietic Cell TransplantationStem Cell and Kidney Transplant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxVenetoclax 400mg orally once daily on days -8 through -1 with daily monitoring for tumor lysis syndrome. Venetoclax tablets will be swallowed (not crushed). Venetoclax dosing will not be repeated in the event of vomiting. | Drug | Recipient |
| Hematopoietic Cell Transplantation Conditioning RegimenCytoxan Day -6 \& -5 Fludarabine Day -4, -3, -2 TBI Day -1 | Procedure or surgery | Recipient |
| Kidney TransplantLiving donor kidney transplant | Procedure or surgery | Recipient |
| Hematopoietic Cell TransplantationDonor bone marrow (target of 4 x 108 nucleated cells/kg of recipient ideal body weight) PBSC A goal dose of 5 x 106 CD34+ cells / kg of recipient actual body weight will be infused (minimum acceptable is 2 x 106 CD34+ cells / kg). | Procedure or surgery | Recipient |
Primary outcome
Incidence of full donor chimerism
Time frame: 24 months
Incidence of Grade IV Toxicity due to Venetoclax
Time frame: Days -8 to Days -1
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Incidence of Grade V Toxicity due to Venetoclax
Time frame: Days -8 to Days -1
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
6 secondary outcomes
Incidence of acute renal allograft rejection
Time frame: 24 months
Incidence of delayed renal allograft rejection
Time frame: 24 months
Incidence of acute GVHD
Time frame: 24 months
Incidence of Chronic GVHD
Time frame: 24 months
Patient Survival Rate
Time frame: 24 months
Allograft Survival Rate
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Venetoclax, Hematopoietic Cell Transplantation Conditioning Regimen and Kidney Transplant in people with Kidney Failure Chronic and Stem Cell Transplant, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Spitzer, MD (617-724-1124, tspitzer@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of full donor chimerism (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.