Phase 4
Completed N=25
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients
Source: ClinicalTrials.gov NCT02953873 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Dec 2019
Primary outcomePrimary: Dose-normalized Trough — 0.59; 0.44 ng/dL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Compare the difference in dose-normalized trough and total daily dose necessary to reach the steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African American kidney transplant recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose-normalized Trough |
0.59; 0.44 | — |
| SECONDARY Total Daily Dose |
10; 15 | — |
| SECONDARY Weight-Based Dose Requirement |
0.11; 0.16 | — |
| SECONDARY Number of Days to Reach Therapeutic Trough Goal |
15; 10; 15 | — |
| SECONDARY Dose Modifications |
1; 2; 4 | — |
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Signed informed consent
- African American race
- History of a solitary renal transplant
- Stable tacrolimus dose for at least 2 weeks prior to randomization
Exclusion Criteria
- 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
- Currently enrolled in an investigational drug trial
- History of a non-renal organ transplant
- History of acute cellular rejection within 1 month prior to randomization
- An increase in serum creatinine by > 20% in the 2 weeks prior to randomization
- Maintenance immunosuppression that does not consist of tacrolimus IR given twice daily, mycophenolate mofetil > 1000mg TDD or mycophenolate sodium > 720mg TDD, and prednisone ≥ 5mg daily
Data sourced from ClinicalTrials.gov (NCT02953873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.