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Immunosuppressant Medication Dosed Daily After Kidney Transplant

NCT ID: NCT04156204

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-20

Study Completion Date

2020-11-27

Brief Summary

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Medication non-adherence is a major risk factor for graft dysfunction and graft loss among pediatric and adult transplant recipients. Rates of non-adherence in these populations are estimated between 30 and 70%, with the highest prevalence in adolescent and young adult (AYA) transplant recipients. Treatment-related factors known to impact rates of adherence include the number of medication doses per day and the number of tablets or capsules a patient takes per day, or "pill burden". One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations. The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited.

Detailed Description

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One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations.3 The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited. Two studies have demonstrated safe and effective conversion of twice-daily tacrolimus to the Astagraf® in stable pediatric solid organ transplant recipients.4,5 Patients maintained equivalent tacrolimus exposure and experienced similar rates of rejection and graft loss in the first year post-conversion.5 To date, experience with another once-daily extended release (XR) tacrolimus product, Envarsus XR®, has not been published in the AYA population. Additionally, adherence studies evaluating a once-daily immunosuppression regimen including extended-release tacrolimus and azathioprine (which is dosed once daily as opposed to the twice daily dosing required for azathioprine's alternative mycophenolate mofetil) have not been conducted.

Of note, and even though twice-daily mycophenolate has been shown to be superior to once-daily azathioprine early post-transplant, more long-term data suggest that this advantage may not persist.6 Furthermore, a recent Cochrane review addressed the question of mycophenolate versus azathioprine as primary anti-proliferative immunosuppression for kidney transplant recipients; it concluded that "balancing the benefits and harms of the two drugs remains a major task of the transplant physician to decide which agent" is appropriate for the individual patient. 7 Moreover, once-daily immunosuppression with tacrolimus extended-release and once-daily azathioprine has been used with excellent results at a British center that focusses on AYA kidney transplant recipients.

Conditions

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Kidney Transplant Rejection Medication Adherence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Longitudinal Pilot Study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Adolescent and Young Adult (AYA) Kidney Transplant Recipients

AYA kidney transplant recipients will receive a Medication Event Monitoring System (MEMS) in the form of a medication bottle and cap system and once daily tacrolimus XR 1-10mg

Group Type EXPERIMENTAL

Medication Event Monitoring System (MEMS)

Intervention Type OTHER

AYA kidney recipients will receive a Medication Event Monitoring System (MEMS) via medication bottle and cap system

Once-Daily Tacrolimus extended release

Intervention Type DRUG

AYA kidney recipients will receive once daily tacrolimus XR 1-10mg daily

Interventions

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Medication Event Monitoring System (MEMS)

AYA kidney recipients will receive a Medication Event Monitoring System (MEMS) via medication bottle and cap system

Intervention Type OTHER

Once-Daily Tacrolimus extended release

AYA kidney recipients will receive once daily tacrolimus XR 1-10mg daily

Intervention Type DRUG

Other Intervention Names

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Envarus XR

Eligibility Criteria

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Inclusion Criteria

1. Age 13-22 years
2. Tanner stage 4/5
3. "Stable" kidney transplant status, as determined by the primary transplant team

Exclusion Criteria

1. \< Tanner stage 4
2. Kidney transplant performed at an institution other than Children's Hospital Colorado, Lurie Children's Hospital of Chicago, or Cincinnati Children's Hospital
3. Recipients of dual solid organ transplants (i.e. heart kidney, liver kidney).
Minimum Eligible Age

13 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Goebel, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Mary Chandran, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Foster BJ, Dahhou M, Zhang X, Platt RW, Samuel SM, Hanley JA. Association between age and graft failure rates in young kidney transplant recipients. Transplantation. 2011 Dec 15;92(11):1237-43. doi: 10.1097/TP.0b013e31823411d7.

Reference Type BACKGROUND
PMID: 22124283 (View on PubMed)

Sabaté, E (2003) Adherence to long-term therapies: evidence for action. World Health Organization, Geneva

Reference Type BACKGROUND

Steinberg EA, Moss M, Buchanan CL, Goebel J. Adherence in pediatric kidney transplant recipients: solutions for the system. Pediatr Nephrol. 2018 Mar;33(3):361-372. doi: 10.1007/s00467-017-3637-0. Epub 2017 Mar 27.

Reference Type BACKGROUND
PMID: 28349215 (View on PubMed)

Min SI, Ha J, Kang HG, Ahn S, Park T, Park DD, Kim SM, Hong HJ, Min SK, Ha IS, Kim SJ. Conversion of twice-daily tacrolimus to once-daily tacrolimus formulation in stable pediatric kidney transplant recipients: pharmacokinetics and efficacy. Am J Transplant. 2013 Aug;13(8):2191-7. doi: 10.1111/ajt.12274. Epub 2013 Jun 4.

Reference Type BACKGROUND
PMID: 23734831 (View on PubMed)

Heffron TG, Pescovitz MD, Florman S, Kalayoglu M, Emre S, Smallwood G, Wisemandle K, Anania C, Dhadda S, Sawamoto T, Keirns J, Fitzsimmons W, First MR. Once-daily tacrolimus extended-release formulation: 1-year post-conversion in stable pediatric liver transplant recipients. Am J Transplant. 2007 Jun;7(6):1609-15. doi: 10.1111/j.1600-6143.2007.01803.x.

Reference Type BACKGROUND
PMID: 17511684 (View on PubMed)

Clayton PA, McDonald SP, Chapman JR, Chadban SJ. Mycophenolate versus azathioprine for kidney transplantation: a 15-year follow-up of a randomized trial. Transplantation. 2012 Jul 27;94(2):152-8. doi: 10.1097/TP.0b013e31825475a3.

Reference Type BACKGROUND
PMID: 22728292 (View on PubMed)

Wagner M, Earley AK, Webster AC, Schmid CH, Balk EM, Uhlig K. Mycophenolic acid versus azathioprine as primary immunosuppression for kidney transplant recipients. Cochrane Database Syst Rev. 2015 Dec 3;2015(12):CD007746. doi: 10.1002/14651858.CD007746.pub2.

Reference Type BACKGROUND
PMID: 26633102 (View on PubMed)

Other Identifiers

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17-2311

Identifier Type: -

Identifier Source: org_study_id