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Conditioning Regimen for Chimerism in Kidney Transplant

Phase 1
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidate for a living-donor renal allograft from an HLA mismatched donor
First transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months after immunosuppression withdrawal
Awards & highlights

Study Summary

This trial is testing whether a new conditioning regimen is safe and can induce donor/recipient lymphohematopoietic chimerism, which may result in donor-specific unresponsiveness to the renal allograft.

Who is the study for?
This trial is for adults aged 18-60 with chronic kidney disease or end-stage renal disease on dialysis, awaiting their first kidney transplant from a living donor. They must have been exposed to EBV, not be pregnant or breastfeeding, and use approved contraception. Exclusions include poorly controlled diabetes, severe organ dysfunction, certain infections (HIV/Hepatitis), recent cancer history except specific skin/cervical cancers, and allergies to trial drugs.Check my eligibility
What is being tested?
The study tests a conditioning regimen aiming to create mixed chimerism—a state where both donor and recipient cells coexist—without causing Chimerism Transition Syndrome. Success could lead to tolerance of the new kidney without long-term immunosuppression.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response such as inflammation in various organs due to Siplizumab or other drugs used in the regimen. There might also be general side effects like fatigue or issues related to blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for a kidney transplant from a donor who doesn't fully match my tissue type.
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This is my first time receiving a transplant.
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I am between 18 and 60 years old.
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I have chronic kidney disease and am on dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months after immunosuppression withdrawal
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months 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 Chimerism Transition Syndrome
Incidence of Transient Chimerism
Incidence of tolerance induction

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,425 Total Patients Enrolled
6 Trials studying Kidney Failure
837 Patients Enrolled for Kidney Failure

Media Library

Conditioning Regimen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04540380 — Phase 1
Kidney Failure Research Study Groups:
Kidney Failure Clinical Trial 2023: Conditioning Regimen Highlights & Side Effects. Trial Name: NCT04540380 — Phase 1
Conditioning Regimen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04540380 — Phase 1

Frequently Asked Questions

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

Is geriatric participation permitted in this analysis?

"To meet the eligibility requirements for this clinical trial, applicants must be aged between 18 to 55. Furthermore, there are 6 studies available for younger patients and 171 trials specifically catered towards those over 65 years old."

Answered by AI

Is enrollment for this trial currently accessible to potential participants?

"Affirmative. According to the data on clinicaltrials.gov, this trial is actively enrolling participants since its inception on September 1st 2021. The study requires 6 individuals from one medical centre and was last modified on December 16th 2021."

Answered by AI

What level of risk does this treatment pose to individuals?

"Since this is a Phase 1 trial, meaning there are only preliminary data supporting safety and efficacy, the team at Power gave it an overall score of 1."

Answered by AI

How many individuals are currently taking part in this clinical investigation?

"Indeed, clinicaltrials.gov attests that this trial is actively seeking participants. The initial post was on the 1st of September 2021 with the last edit being done on December 16th 2021; 6 patients from a single site are needed for completion."

Answered by AI

Do I satisfy the prerequisites of this research project?

"This research is allowing six individuals with kidney failure, aged 18 to 55 years old, the opportunity to participate. Applicants must satisfy various criteria: be a possible recipient of an organ from an HLA mismatched donor; have chronic kidney disease or end-stage renal disease (ESRD) and receive dialysis treatments; already had at least one transplant before; and be either male or female in between 18 to 60 years of age."

Answered by AI
~4 spots leftby Jan 2025