Apheresis for Kidney Transplant

Phase-Based Progress Estimates
University of Kentucky Medical Center, Lexington, KYKidney Transplant+1 MoreApheresis - Procedure
18 - 65
All Sexes
What conditions do you have?

Study Summary

This trial is investigating the use of Treg cells to prevent kidney rejection in patients undergoing a solitary kidney transplant. 12 participants will be enrolled at the University of Kentucky.

Eligible Conditions
  • Kidney Transplant
  • Kidney Failure

Treatment Effectiveness

Study Objectives

4 Primary · 2 Secondary · Reporting Duration: 6 to 12 weeks post transplant

Month 12
Changes In Steroid Resistance Rejection Rates
Week 12
Treg cell measurements within the allograft
Hour 24
Changes in Tregs Infusion Toxicities
Year 2
Changes in Kidney Function
Infectious Complications
Month 3
Circulating T cell subset measurements

Trial Safety

Side Effects for

Abl Cells IV + Cyclophosphamide 30 mg/kg
100%Neutrophil count decreased
100%Leukocyte count decreased
100%Lymphocyte count decreased
33%Hemoglobin decreased
33%Serum albumin decreased
33%Bilirubin increased
This histogram enumerates side effects from a completed 2010 Phase 2 trial (NCT00001832) in the Abl Cells IV + Cyclophosphamide 30 mg/kg ARM group. Side effects include: Neutrophil count decreased with 100%, Leukocyte count decreased with 100%, Lymphocyte count decreased with 100%, Hemoglobin decreased with 33%, Serum albumin decreased with 33%.

Trial Design

1 Treatment Group

Autologous Treg Infusion
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Apheresis · No Placebo Group · N/A

Autologous Treg Infusion
Experimental Group · 1 Intervention: Apheresis · Intervention Types: Procedure
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 to 12 weeks post transplant

Who is running the clinical trial?

Roberto GedalyLead Sponsor
1 Previous Clinical Trials
78 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,735 Previous Clinical Trials
3,544,031 Total Patients Enrolled
Roberto Gedaly, MDPrincipal Investigator - University of Kentucky
University of Kentucky Albert B. Chandler Hospital
University Central De Venezuela (Medical School)
2 Previous Clinical Trials
78 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

Is it possible for me to participate in this research endeavor?

"To qualify for this research initiative, prospective participants must have kidney failure, be of chronic nature and fall within the age range of 18-65. Approximately 12 recruits are needed to participate in this study." - Anonymous Online Contributor

Unverified Answer

Does this clinical trial include participants under the age of 40?

"This trial can accommodate participants aged 18 to 65. There are 23 independent studies for those younger and 246 trials specifically tailored to the elderly population." - Anonymous Online Contributor

Unverified Answer

How many participants are taking part in this experiment?

"Affirmative. The information available on clinicaltrials.gov attests that this medical trial, initially published on March 15th 2019, is actively recruiting patients. A single site is admitting 12 people for the study." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities currently available to enroll in this research?

"Affirmative. The relevant data found on clinicaltrials.gov confirms that this medical study, which was first listed on March 15th 2019, is actively seeking subjects to enrol in the trial. A mere 12 patients are required from 1 site for participation and the last update occurred on May 16th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.