Last reviewed · How we verify
NCT04838288: OPERATOR
Cognitive Outcomes in Stable Renal Transplant Patients Switched FromTacrolimus to Envarsus XR™
Phase 4 trial testing Change from Prograf to Envarsus XR in Renal Transplant in 60 participants. Participants enrolled and being followed up; not accepting new ones.
31 January 2026
Quick facts
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 22 June 2021 |
| Primary completion | 31 January 2026 |
| Estimated completion | 31 January 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Change from Prograf to Envarsus XR — full drug profile →
Conditions studied
- Renal Transplant — all drugs for Renal Transplant →
Sponsor
Vanderbilt University Medical Center
Who can join
Adults 18 to 70, any sex, with Renal Transplant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess cognitive outcome and quality of life in stable renal transplant patients treated with twice daily tacrolimus at baseline and after switching to Envarsus XL. The study is designed to see if switching patients from Tacrolimus to Envarsus treatment improves cognitive function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04838288
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Vanderbilt University Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04838288 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
- Last refreshed: 6 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04838288.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing