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Cell Therapy

Everolimus for Kidney Transplant (TASK Trial)

Phase 1 & 2
Waitlist Available
Led By Flavio Vincenti, MD
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 weeks after infusion (polytregs group) and 7 months after group allocation
Awards & highlights

TASK Trial Summary

This trial is testing if a new treatment, polyTregs, can reduce inflammation in people who have recently had a kidney transplant. The researchers will also be looking at what effects, both good and bad, polyTregs and a second medication, everolimus, have on people who have received a kidney transplant.

Eligible Conditions
  • Kidney Transplant
  • Living Kidney Donors

TASK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 weeks after infusion (polytregs group) and 7 months after group allocation
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 weeks after infusion (polytregs group) and 7 months after group allocation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immunologic profiles of kidney transplant recipients
Incidence of Banff 2A or higher acute cell-mediated rejection and/or acute antibody mediated rejection
Incidence of study defined Grade 3 or higher infection
+3 more
Secondary outcome measures
Incidence of > 10% decrease in estimated Glomerular Filtration Rate (eGFR) compared to baseline
Incidence of BK viremia
Incidence of acute rejection after converting to mTOR therapy following polyTregs infusion
+17 more

TASK Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Polyclonal Regulatory T Cells groupExperimental Treatment11 Interventions
Subjects to receive polyTregs (550 ± 450 x 10^6). After receiving at least 300X10^6 polyTregs infusion, eligible subjects will start mammalian Target of Rapamycin (mTOR) inhibitor. Target tacrolimus trough levels prior to conversion to everolimus are 4-11 μg/dl, which falls within standard of care. For eligible participants in polyTregs and darTregs groups, the tacrolimus dose will be reduced by 50% when everolimus is initiated. Tacrolimus will be discontinued 4 weeks after initiation of everolimus therapy. Everolimus, a mTOR inhibitor immunosuppressant, will be initiated at a dose of 1.5 mg orally twice daily and titrated, as needed. Participants will begin everolimus with target trough levels of 3-8μg/L for 4 weeks while still taking tacrolimus. Everolimus target trough levels will be 6-10 μg/L when tacrolimus is discontinued. (N=7 participants in this group)
Group II: Maintenance CNI based immunosuppression therapy groupActive Control5 Interventions
Standard of care (N=7 participants in this group)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polyclonal Regulatory T Cells
2016
Completed Phase 2
~20
Everolimus
2010
Completed Phase 4
~1510
Tacrolimus
2011
Completed Phase 4
~4740
Mycophenolate mofetil
2014
Completed Phase 4
~2350
Mycophenolic acid
2017
Completed Phase 4
~1230
Acetaminophen
2017
Completed Phase 4
~2030
Diphenhydramine
2002
Completed Phase 4
~1170
Biopsy, Kidney
2016
Completed Phase 2
~20
Blood Draw
2006
Completed Phase 4
~2400
Leukapheresis
2016
Completed Phase 2
~690
IS regimen conversion
2016
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,686 Total Patients Enrolled
Clinical Trials in Organ TransplantationNETWORK
17 Previous Clinical Trials
4,058 Total Patients Enrolled
Flavio Vincenti, MDPrincipal InvestigatorUniversity of California at San Francisco
4 Previous Clinical Trials
41 Total Patients Enrolled

Frequently Asked Questions

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

Are there still vacancies for participants within this research?

"Affirmative. According to data collected on clinicaltrials.gov, this medical trial is currently seeking participants for its study; first posted in September of 2016 and most recently updated on February 22nd 2022. 14 volunteers from 6 different medical centres are needed for the research project."

Answered by AI

What ailments does the Biopsy, Kidney procedure typically address?

"Biopsy, Kidney is a commonly used treatment for dermatitis atopic and other medical issues such as catarrh, lung disease and advanced carcinoid tumor."

Answered by AI

What other investigations have been conducted regarding renal tissue sampling?

"Presently, 392 clinical trials exploring Biopsy, Kidney are in progress. 67 of these ongoing studies have advanced to the third phase of research. While many sites for this kind of treatment can be found in Philadelphia, Pennsylvania, there exists a total 6111 locations running experiments related to Biopsy and Kidney health."

Answered by AI

How widespread is this investigation in the Canadian healthcare system?

"Presently, the research team is enrolling participants from 6 sites located in Cleveland, Ann Arbor and San Francisco as well as 3 extra cities. To reduce your travel needs when participating in this trial it may be best to select the closest location."

Answered by AI

How many participants is the research team recruiting for this experiment?

"To complete this study, 14 volunteers with the right eligibility requirements must participate. Prospective participants may enrol at either Cleveland Clinic in Ohio or University of Michigan in Ann Arbor, MI."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California at San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I enjoy the information gathered to help others.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Treg Therapy in Subclinical Inflammation in Kidney Transplantation
2016. "Treg Therapy in Subclinical Inflammation in Kidney Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02711826.
~2 spots leftby Apr 2025
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