Boston, MANCT06972069Now EnrollingIRB Ready

Kidney Failure Clinical Trial in Boston, MA

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

Sponsored by Tatsuo Kawai, MD, PhD

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 is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.

Sponsor: Tatsuo Kawai, MD, PhD

Who Can Participate

Inclusion Criteria

Male or female 18-65 years of age.
Subjects with chronic kidney disease stage V (GFR\<15ml/min/1.73m2) or ESRD who are treated or imminently be treated with either hemodialysis or peritoneal dialysis.
Candidate for a living-donor renal allograft from an HLA matched or mismatched donor
First or second renal transplant.
EBV Seropositive
Use of FDA-approved methods of contraception by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation
Ability to understand and provide informed consent.
Negative COVID-19 test during screening and two days prior to procedure Recipient

Exclusion Criteria

ABO blood group-incompatible renal allograft
Participant with a donor-specific antibody (DSA) within 6 months prior to transplant
Persistent Leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (\<100,000/mm3)
Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA); or positivity for hepatitis B surface antigen.
Untreated 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.
Patients with active cancer or those with a high risk of recurrence following the American Transplant Society
Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as non-genetic primary focal segmental glomerulosclerosis dense deposit disease, C3 glomerulonephritis, and, atypical hemolytic uremic syndrome).
Prior dose-limiting radiation therapy for treatment of malignant disease.
Known genetic disease or family history that may result in greater sensitivity to the effects of irradiation, or a physical deformity that would preclude adequate shielding or appropriate dosing during the irradiation component of the conditioning regimen. This includes long term cigarette smoking or a family history of malignancy.
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 Cyclophosphamide, tacrolimus, Siplizumab, Tegoprubart, or rituximab.
The presence of 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.
Any chronic or intermittent administration of immunosuppressant medication (such as for inflammatory bowel disease or asthma)
Subjects who have non-insulin dependent diabetes (NIDDM) without good blood glucose control (HbA1c\<8%). Subjects with severe diabetes-related complications, such as advanced retinopathy, gastroparesis, or severe neuropathy that significantly impair their ability to perform normal, independent daily activities, will also be excluded. Donor Inclusion Criteria:
Male or female 18-70 years of age.
For females of childbearing potential: a serum pregnancy test showing negative results.
Excellent health per conventional pre-donor workup (medical and psychosocial evaluation)
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 HBV (HbsAg and NAT), HIV (antibody and NAT), HCV (NAT), or HTLV-1.
Cardiac/pulmonary function within normal limits (CXR, ECG).
Ability to understand and provide informed consent.
Meets standard institutional criteria for bone marrow aspiration and kidney donation.
Negative COVID-19 test during screening and two days prior to procedure

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 (NCT06972069) 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 (NCT06972069) 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 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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