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Immunosuppressant

Immunosuppression reduction for Immunosuppression

Phase 4
Waitlist Available
Led By Hannah Gilligan, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Blood biomarkers indicate immune quiescence (for Allosure this corresponds to dd-cfDNA < 1%; for Trugraf this corresponds to "TX" signature)
Stable renal function (eGFR > 40 ml/min continuously during previous 6 months)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, 1 year
Awards & highlights

Study Summary

This trial is testing whether two new blood tests can help doctors safely convert patients from a dual immunosuppressive regimen to belatacept monotherapy.

Eligible Conditions
  • Immunosuppression
  • Kidney Transplant Rejection

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 1 year 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 Acute Rejection
Secondary outcome measures
Incidence of de Novo Donor Specific Antibodies
Increase in eGFR
Rate of New-onset Proteinuria
+1 more

Side effects data

From 2023 Phase 4 trial • 17 Patients • NCT04177095
17%
Elevated Creatinine
8%
Fatigue
8%
Proteinuria
8%
Elevated LFTs
8%
Urinary Tract Infection
8%
Knee Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept Treated Patients

Trial Design

1Treatment groups
Experimental Treatment
Group I: Belatacept treated patientsExperimental Treatment3 Interventions
Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trugraf
2020
Completed Phase 4
~20
Allosure
2020
Completed Phase 4
~20
Prednisone
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,920 Previous Clinical Trials
13,193,291 Total Patients Enrolled
Transplant Genomics, Inc.Industry Sponsor
13 Previous Clinical Trials
3,983 Total Patients Enrolled
1 Trials studying Immunosuppression
75 Patients Enrolled for Immunosuppression
CareDxIndustry Sponsor
25 Previous Clinical Trials
15,454 Total Patients Enrolled
3 Trials studying Immunosuppression
980 Patients Enrolled for Immunosuppression

Frequently Asked Questions

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

What is the approximate size of this medical experiment's participant pool?

"Unfortunately, this clinical trial has ceased its recruitment efforts. The details were uploaded on February 11th 2020 and the last amendment was made September 2nd 2021. As an alternative, there are currently 56 studies seeking participants with immunosuppression and 445 trials researching Immunosupression reduction that are actively looking for volunteers."

Answered by AI

What other investigations have been conducted to gauge the efficacy of Immunosuppression reduction?

"Currently, 445 clinical trials exploring Immunosuppression reduction are ongoing. Out of those studies, 112 have progressed to the third phase of testing. Much of this research is being conducted in Duarte, California but there exist 20597 sites running these experiments worldwide."

Answered by AI

Is there still capacity for new participants to join this research?

"Sadly, this clinical trial has already ended recruitment. It first began on February 11th 2020 and was last updated September 2nd 2021. However, there are still 56 studies searching for immunosuppressed participants and 445 trials actively recruiting patients who wish to reduce their Immunosuppression levels."

Answered by AI

To what extent do the risks outweigh the benefits of immunosuppression reduction?

"Immunosuppression reduction has earned a score of 3, thanks to the Phase 4 status that confirms it is an approved medication."

Answered by AI

To what medical afflictions is immunosuppression reduction commonly applied?

"Immunosuppression reduction is regularly used in the treatment of lung-related conditions. Additionally, this technique can be applied to combat advanced carcinoid tumor, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."

Answered by AI
~3 spots leftby Mar 2025