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Calcineurin Inhibitor

Envarsus XR for Kidney Transplant Rejection

Phase 4
Waitlist Available
Led By Mark Hardy, MD
Research Sponsored by Columbia University
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 through study completion, an average of 1 year
Awards & highlights

Study Summary

This is a one year, prospective, randomized, open-label trial examining once versus twice daily tacrolimus dosing regimen using two preparations, extended-release Tacrolimus (Envarsus XR) versus twice daily Tacrolimus (Prograf). It will examine kidney function between the two groups using estimated glomerular filtration rate (eGFR) and also examine one-year kidney outcomes, including graft loss and patient death. Patients will be followed for up to 1 year during the open-label study period.

Eligible Conditions
  • Kidney Transplant Rejection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
C/D Ratio
Secondary outcome measures
Estimated Glomerular Filtration Rate (eGRF)
Graft Survival Rate
Number of Serious Adverse Events
+2 more

Side effects data

From 2022 Phase 4 trial • 97 Patients • NCT03020589
98%
Anemia
83%
Hypomagnesemia
75%
Leukopenia
70%
Hyperkalemia
57%
Abnormal renal function
50%
Hypophosphatemia
50%
Increase creatinine
45%
Hyperglycemia
33%
Delayed Graft Function Requiring Dialysis
30%
Diarrhea
30%
Nausea
28%
Headache
28%
Hypertension
25%
Tremor
25%
Infection
23%
Constipation
23%
Edema
20%
Vomiting
18%
Hyperlipidemia
18%
Hypokalemia
10%
Biopsy Proven Acute Rejection
8%
Neurotoxicity
3%
Graft loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
CYP3A5 Based Tacrolimus Dosing
Control

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Envarsus XRExperimental Treatment1 Intervention
Envarsus XR (Tacrolimus Extended Release Oral Tablet) will be administered once daily at initial weight-based dose of 0.12 mg/kg. Dosing and monitoring thereafter predicated on clinical judgment to a minimum whole blood tacrolimus concentration of at least 8 ng/mL. When possible, patients will receive their daily dose of Envarsus using the fewest number of pills possible.
Group II: Tacrolimus, Immediate releaseActive Control1 Intervention
Tacrolimus (immediate-release) will be administered twice daily per clinical judgment of supervising physician (dosing and monitoring in accordance with center protocol) to a minimum whole blood tacrolimus concentration of at least 8 ng/mL.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,427 Previous Clinical Trials
2,459,810 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,096 Total Patients Enrolled
Mark Hardy, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation
Mark A Hardy 2018. "Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03511560.
All > Kidney Transplant
~7 spots leftby Apr 2025
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