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Bone Marrow Transplant for Kidney Failure

Phase 1 & 2

Recruiting

Led By Tatsuo Kawai

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female 18-65 years of age

Kidney transplant recipients from either LD or DD, with cryo-preserved HSCs available, good renal function (GFR>45 ml/min/1.73m2), normal current allograft biopsy, and no history of documented rejection episodes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years after immunosuppression withdrawal

Awards & highlights

Study Summary

This trial will study the impact of a bone marrow transplant before or after kidney transplant, with treatment to protect the kidney from being rejected.

Who is the study for?

Adults aged 18-65 with kidney failure who've had a transplant and show good renal function, without rejection history or severe health issues. Must have prior EBV exposure, use reliable contraception, and test negative for COVID-19. Living donors must be healthy and meet criteria for stem cell donation; deceased donors' families must consent to bone marrow donation.Check my eligibility

What is being tested?

The trial tests the safety and effectiveness of a bone marrow transplant following a kidney transplant using additional treatments including an investigational drug to prevent immune attack on the new kidney.See study design

What are the potential side effects?

Potential side effects may include reactions to medications like Cyclophosphamide or Rituximab such as nausea, hair loss, low blood counts leading to infection risk, allergic reactions, liver problems, or lung issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I had a kidney transplant with good kidney function, no rejection history, and a normal biopsy.

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I am undergoing my first or second kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years after immunosuppression withdrawal

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years after immunosuppression withdrawal

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after immunosuppression withdrawal for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of renal allograft tolerance

Incidence of transient mixed chimerism

Secondary outcome measures

Incidence of Allograft Rejection

Incidence of Chimeric Transition Syndrome

Incidence of DSA

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Kidney and Stem Cell RecipientsExperimental Treatment5 Interventions

Months-Years after standard transplant, patients will undergo bone marrow transplant (either from prospective collection of stem cells from their living donor, or from bone marrow collected at the time of deceased donation)

Group II: Kidney and Stem Cell DonorsExperimental Treatment1 Intervention

PBSC will be collected from the LD via leukapheresis 1-4 weeks before the scheduled HSCT. The donor will first undergo standard GCSF mobilization: GCSF (can be TBO-GCSF) dosed at 10 mcg/kg/d (rounded to nearest pre-filled syringe) administered subcutaneously daily for 5 consecutive days. On the 5th day, the donor will undergo standard large volume leukapheresis. The target yield will be 2-3 x 106 CD34+ cells / kg of actual recipient body weight. A maximum of 3 days of pheresis will be allowed. A minimum of 2 x 106 CD34+ cells / kg of actual recipient body weight will be required to proceed

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

Siplizumab

2009

Completed Phase 1

~20

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,621 Total Patients Enrolled

6 Trials studying Kidney Failure

837 Patients Enrolled for Kidney Failure

Ossium Health, Inc.Industry Sponsor

9 Previous Clinical Trials

128 Total Patients Enrolled

ITB-Med LLCIndustry Sponsor

9 Previous Clinical Trials

311 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction of this trial limited to individuals over 55 years old?

"This research study is looking for individuals aged 18 or more, but not exceeding 65 years of age."

Answered by AI

Is registration for this experiment still open?

"According to the data on clinicaltrials.gov, this experiment is recruiting participants at present. The trial was initially published on October 1st 2023 and its post was most recently revised on October 4th 2023."

Answered by AI

What is the total number of individuals enrolled in this clinical investigation?

"Affirmative. According to the information on clinicaltrials.gov, this trial is currently seeking participants and has been since October 1st 2023 when it was initially posted. The study requires a total of 20 volunteers from one medical centre and was last edited four days later on 10/4/2023."

Answered by AI

What kind of participants are most suitable to be recruited for this research?

"This clinical trial is enrolling 20 individuals with renal impairment aged between 18 and 65. In order to apply, applicants must meet the outlined criteria: Recipient Inclusion Criteria, Male or female of legal age., Kidney transplant recipients from either LD or DD (with cryo-preserved HSCs available), adequate glomerular filtration rate (>45 ml/min/1.73m2) as evidenced by laboratory tests, normal current allograft biopsy results, no history of documented rejection episodes., First or second kidney transplantation., Utilization of FDA-approved methods of contraception (those with a failure"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Delayed Tolerance Through Mixed Chimerism

Tatsuo Kawai, MD, PhD 2023. "Delayed Tolerance Through Mixed Chimerism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05900401.