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Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02954198
Recruitment Status : Completed
First Posted : November 3, 2016
Results First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
With the availability of well-studied once-daily formulations of tacrolimus, the ability to achieve a true once-daily immunosuppressant regimen along with everolimus and steroids may finally be achievable and have the potential to optimize immunosuppression safety and efficacy in kidney transplantation.

Condition or disease Intervention/treatment Phase
Immunosuppression Drug: Tacrolimus Drug: Prednisone Drug: Mycophenolate mofetil Drug: Everolimus Not Applicable

Detailed Description:
A once-daily immunosuppressant regimen comprising of Envarsus-everolimus-prednisone will have 6-month treatment failure rates that are non-inferior to the twice-daily regimen of Envarsus-mycophenolate mofetil-prednisone and will have improved patient-reported adherence.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : December 27, 2018
Actual Study Completion Date : December 27, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Active Comparator: Tacrolimus + MMF
Tacrolimus IR BID (5-12ng/mL) + mycophenolate mofetil 1g BID + prednisone x at least 3 months, then converted to Tacrolimus Daily (5 -12ng/mL) + mycophenolate mofetil 1g BID + prednisone x 6 months
Drug: Tacrolimus
goal trough level 5-12ng/mL
Other Name: Envarsus

Drug: Prednisone
goal dose 5mg QD
Other Names:
  • Corticosteroids
  • Methylprednisolone

Drug: Mycophenolate mofetil
goal dose 1g BID

Active Comparator: Envarsus + Everolimus
Tacrolimus IR BID (5-12ng/mL) + mycophenolate mofetil 1g BID + prednisone x at least 3 months, then converted to Envarsus Daily (2-5ng/mL) + Everolimus Daily (3-8ng/mL) + prednisone x 6 months
Drug: Tacrolimus
goal trough level 5-12ng/mL
Other Name: Envarsus

Drug: Prednisone
goal dose 5mg QD
Other Names:
  • Corticosteroids
  • Methylprednisolone

Drug: Everolimus
goal trough level 3-8ng/mL




Primary Outcome Measures :
  1. Self-reported Medication Adherence From Baseline to 6 Months. [ Time Frame: 6 months post conversion ]
    Percent of subjects reporting high medication adherence at baseline compared to 6 months post-conversion, using the Morisky Medication Adherence scale (MMAS). The MMAS rates medication adherence on a scale of 0 to 8. 0 is high adherence, 1-2 is medium adherence, and greater than or equal to 3 is low adherence.


Secondary Outcome Measures :
  1. Percent of Participants Experiencing Acute Allograft Rejection [ Time Frame: Baseline to 6 months post conversion ]
    Estimate the composite of treatment failure rate, defined as acute allograft rejection with a Banff grade 1A or higher, graft loss, or death at six months post-conversion, in patients converted to a once-daily immunosuppressant regimen of Envarsus®, everolimus, and prednisone versus patients converted to a twice-daily regimen of Envarsus®, MMF, and prednisone.


Other Outcome Measures:
  1. Subject Specific Change on Medication Side Effect Scale [ Time Frame: Baseline to 6 months post conversion ]
    Examine subject specific change on a validated Medication Side Effect Scale at the time of the conversion versus six months post-conversion, compared between the two arms. Side effect burden scale is from 0 to 180. A lower score is less side effect burden, a higher score is more side effect burden.

  2. Percent of Participants Who Experienced Kidney Transplant Graft Loss [ Time Frame: Baseline to 6 months post conversion ]
    Measure and compare time-to-event analysis between the two arms graft loss (time to event analysis)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

1. Inclusion criteria

  1. Male or female adult (≥18 years old) with a history of solitary kidney transplant within 3 months (±2 months) of transplant with self-reported medication adherence issues, as indicated by a MMAS-8 of at least 1.
  2. Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.
  3. Women of childbearing potential must have a negative pregnancy test within the 48 hours prior to receiving study medication.
  4. Women of childbearing potential and sexually active males must be willing to use contraception, as indicated in Section 6 of the protocol. Subjects who are not of reproductive potential (status post bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or vasectomy), not sexually active, whose current partner(s) is not of reproductive potential, or whose sexual activity is exclusively homosexual are eligible without requiring the use of contraception.

2. Exclusion criteria

  1. Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner
  2. Recipient of multiple organ transplant
  3. Recipient of a non-renal organ
  4. Proteinuria > 800 mg/24 hour
  5. eGFR < 30 ml/min
  6. WBC ≤ 2k/mm3
  7. Plt ≤ 50k/mm3
  8. Triglycerides > 500 mg/dL
  9. HIV positive (HIV ab +)
  10. Unable to tolerate oral medications
  11. Use of another investigational product within thirty days prior to receiving study medication
  12. Acute graft rejection within the past month (Banff 1A or higher) or received an ABO incompatible donor organ.
  13. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954198


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02954198    
Other Study ID Numbers: Pro00059602
First Posted: November 3, 2016    Key Record Dates
Results First Posted: December 24, 2019
Last Update Posted: December 24, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Mycophenolic Acid
Prednisone
Methylprednisolone
Everolimus
Tacrolimus
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents