Boston, MANCT05900401Now EnrollingIRB Ready

Kidney Failure Clinical Trial in Boston, MA

Access cutting-edge kidney failure treatment through this phase 1/2 clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Massachusetts General Hospital

Quick Self-Assessment

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Expert Care in Boston

Access kidney failure specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related kidney failure treatment provided free

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Check if you qualify for this kidney failure clinical trial in Boston, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Kidney Failure Study in Boston

This study will examine the safety and effectiveness of a bone marrow transplant after kidney transplant (from either a living or deceased donor). An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system

Sponsor: Massachusetts General Hospital

Who Can Participate

Inclusion Criteria

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\>60 ml/min/1.73m2), normal current allograft biopsy, and no history of documented rejection episodes.
First or second renal transplant.
Use of FDA-approved methods of contraception (those with less than a 3% failure rate) by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation. (For further information on FDA- approved methods of contraception, see https://www.fda.gov/media/150299/download
Ability to understand and provide informed consent.
Negative COVID-19 test during screening and two days prior to HSC transplantation (HSCT). Deceased Donor (DD)
Male or female 18-70 years of age.
Consent to donate vertebral bones is obtained from the donor family.
HSCs are successfully cryopreserved and saved \>2X106/kg (CD34+ cells) of the recipient.
Acceptable laboratory parameters (hematology in normal or near-normal range. Liver function \<2 times the upper limit of normal, and normal creatinine)
Negative for viral infection with HbsAg, HIV, HCV, or HTLV-1
Negative COVID-19 test at the time of HSC procurement. Living Donor (LD)
Willingness to provide HSCs by leukapheresis or bone marrow aspiration.
Negative serologic pregnancy test for females of childbearing potential
Good general health as per conventional evaluation for kidney donation.
Acceptable laboratory parameters (hematology in normal or near normal range. Liver function \<2 times the upper limit of normal, and normal creatinine)
Negative for viral infection with HbsAg, HIV, HCV, or HTLV-1.
Cardiac/pulmonary function within normal limits (CXR, ECG).
Ability to understand and provide informed consent.
Meets standard institutional criteria for PBSC collection.
Negative COVID-19 test during screening and two days prior to PBSC collection. Recipient

Exclusion Criteria

ABO blood group-incompatible renal allograft.
Evidence of anti-HLA antibody (donor specific with an MFI \>1000) as assessed by routine methodology (Luminex)
Previous history of biopsy proven rejection.
Persistent Leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (\<100,000/mm3).
Seropositivity for HIV-1, hepatitis B surface or core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA).
Active infection
Left ventricular ejection fraction \< 40% as determined by TTE or clinical evidence of heart failure.
Forced expiratory volume FEV1 or DLCO \< 50% of predicted.
Lactation or pregnancy.
History of cancer (following the American Transplant Society Guidelines)
Underlying renal disease etiology with high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis). Autoimmune diseases such as Lupus and Thrombotic Thrombocytopenic Purpura.
Enrollment in other investigational drug studies within 30 days prior to enrollment.
Abnormal (\>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT), or any patients on chronic anticoagulation therapy.
Allergy or sensitivity to any component of Siplizumab, fludarabine, CP, tacrolimus, MMF or rituximab.
Any medical condition that the investigator deems incompatible with participation in the trial. This includes a history of alcohol abuse or illicit drug use/dependence.
Non-insulin dependent diabetes (NIDDM) without good blood glucose control (HbA1c\<7). Severe retinopathy, gastroparesis, or severe neuropathy which prevent subject's normal independent daily activities.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT05900401) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Kidney Failure Treatment Options in Boston, MA

If you're searching for kidney failure treatment options in Boston, MA, this clinical trial (NCT05900401) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced kidney failure specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all kidney failure clinical trials near you to find additional studies recruiting in your area.

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