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NCT03828058
Envarsus XL Immunosuppression Following Liver Transplantation
Phase 2 trial testing Envarsus XR in Recipients of Liver Transplant in 110 participants. Completed in 31 December 2020.
31 December 2020
Quick facts
| Lead sponsor | Methodist Healthcare |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 1 April 2019 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Envarsus XR
- Prograf — full drug profile →
Conditions studied
- Recipients of Liver Transplant — all drugs for Recipients of Liver Transplant →
Sponsor
Methodist Healthcare — full company profile →
Who can join
18 and older, any sex, with Recipients of Liver Transplant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak concentrations are thought to have lower rates of nephrotoxicity. Additionally, compliance with once daily medications is felt to be easier than twice daily medications. Our aim is to look at our prospective liver transplant group and see if once daily tacrolimus (Envarsus XR) results in improved renal function as well as improved health care quality of life.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03828058
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Envarsus XR
Trials testing the same drug.
- NCT03979365 — Envarsus XR Compared to Immediate Release Tacrolimus · Phase 4 · completed
- NCT03321656 — Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile · Phase 2, PHASE3 · recruiting
- NCT03864926 — Envarsus in Delayed Graft Function (E-DGF) · Phase 4 · completed
- NCT03266393 — Envarsus XR® in Adolescent Renal Transplant Recipients · Phase 4 · active not recruiting
- NCT04665310 — Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant · Phase 4 · active not recruiting
Other Methodist Healthcare trials
Trials by the same sponsor.
- NCT00557375 — Brain Tumor Treatment Satisfaction Survey · completed
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 NCT03828058 (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 Methodist Healthcare
- Last refreshed: 12 January 2021
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/NCT03828058.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing