Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens
Impact of Two Prednisone-free Maintenance Immunosuppressive Regimens With Reduced Dose FK506+Everolimus vs. Standard Dose Tacrolimus (FK506)+ Mycophenolate Mofetil (MMF) on Subpopulation of T and B Cells, Renal Allograft Function and Gene Expression Profiles in Renal Allograft Biopsies at 12 Months Post-transplant. Prospective Single Center Study in Recipients of Renal Transplant Allograft.
This date has not been verified as actual or estimated.
Primary Completion
May 2020
Actual (reported)
Study Completion
May 2020
Actual (reported)
Brief Summary
The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking a transplanted organ. The primary purpose of this study is to investigate the impact of two maintenance immunosuppressive regimens. Subjects who enroll in this study will be randomly selected to have tacrolimus and everolimus (group 1) or tacrolimus and mycophenolate mofetil (group 2) as their immunosuppression medication.
This study will enroll adult patients who are scheduled to receive a kidney transplant.
The study is designed to understand the mechanisms of Everolimus in regards to kidney function in transplant recipients. The investigators hypothesis is that decreased exposure to Tacrolimus to the immune system will then translate in better renal allograft function.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
88 participants
Study completion date
May 2020
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
April 4, 2012
Actual (reported)
First Posted
July 31, 2012
Actual (reported)
Study Start
February 2013
Date type not reported
This date has not been verified as actual or estimated.
Evaluate the change in regulatory T cell generation and review the relationship of the newly generated T cells with their function in the two maintenance immunosuppressive regimens at baseline, 3 and 12 months post-transplant.
Baseline, 3 months, and 12 months post-transplant
Change in Glomerular Filtration Rate (GFR)
Evaluate the change in graft function (as measured by GFR) at 12 months post-transplant from baseline.
3 months, 6 months, and 12 months post-transplant
Secondary Outcomes (3)
Patient Survival
baseline - 24 months post transplant
Renal Allograft Survival
12 months post-transplant
Acute Rejection
12 months post transplant
Study Arms (3)
Group 1: Tacrolimus with MMF.
ACTIVE COMPARATOR
This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.
Drug: Tacrolimus with MMF
Group 2: Tacrolimus with Everolimus
ACTIVE COMPARATOR
This group will receive a low dose Tacrolimus with concentration controlled Everolimus
Drug: Group 2: Tacrolimus with Everolimus.
Donors
NO INTERVENTION
One time blood samples will be collected from kidney donors to recipients in this study
Interventions
Tacrolimus with MMFDrug
Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
Also known as: Tacrolimus, FK 506, mycophenolate mofetil, MMF
Group 1: Tacrolimus with MMF.
Group 2: Tacrolimus with Everolimus.
Registry intervention entries
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Partially structured registry wording
Tacrolimus with MMF
Part of this registry label remains unresolved and is preserved as written. Recognized names are text references, not confirmed ingredients. Composition, doses and actual exposure are not established.
Names joined in the label
1 recognized name reference in the wording; 1 unresolved part.
88 participants (actual enrollment reported by the registry).
Study Design
Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor of Transplant Nephrology
Study Record Dates
First Submitted
April 4, 2012
First Posted
July 31, 2012
Study Start
February 2013
Date type not reported
This date has not been verified as actual or estimated.
Drug
From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is \< 3 ng/mL, or reduced if the trough level is \> 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
Also known as: Everolimus, Zortress, Tacrolimus, FK 506
Group 2: Tacrolimus with Everolimus
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects should be single organ recipients (kidney only)
Subjects must be able to understand the protocol and provide informed consent.
Recipient of living donor kidney transplants
Panel reactive antibody (PRA) \< 20%
You may not qualify if:
Subjects with End Stage Renal Disease (ESRD) secondary to primary focal segmental glomerulonephritis (FSGS).
Inability to fully understand the purpose of the study and the inability to sign the informed consent
Subjects with a significant or active infection
Subjects who are pregnant or nursing females
Subjects with a history of severe hyperlipidemia not controlled with statins, patients with Cholesterol \> 400mg/dl
Subjects with a platelet count \< 100,000mm3, WBC \< 2,000mm3 (or clinical practice)
Subjects, who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial.
Contact the study team to confirm eligibility.
Caproates
Acids, Acyclic
Carboxylic Acids
Fatty Acids
Lipids
Sirolimus
Primary Completion
May 2020
Actual (reported)
Study Completion
May 2020
Actual (reported)
Last Updated
March 2, 2021
Results First Posted
March 2, 2021
Record last verified: 2021-02
Source record
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Source: ClinicalTrials.gov.
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