NCT01958190 is a Phase 4 clinical trial of Tacrolimus and Sirolimus in Liver Disease, sponsored by Foundation for Liver Research.

Who is sponsoring NCT01958190?

NCT01958190 is sponsored by Foundation for Liver Research.

What drugs are being tested in NCT01958190?

Interventions in NCT01958190: Tacrolimus and Sirolimus, Tacrolimus.

What condition does NCT01958190 study?

NCT01958190 studies Liver Disease.

Is NCT01958190 still recruiting?

NCT01958190 is currently completed. Last updated 18 March 2022.

Last reviewed 2022-03-18 · How we verify

NCT01958190

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study Comparing in Livertransplantation Recipients With Tacrolimus Alone Versus Tacrolimus&Sirolimus

Completed Phase 4 Last updated 18 March 2022

What this trial tests

Phase 4 trial testing Tacrolimus and Sirolimus in Liver Disease in 196 participants. Completed in 20 May 2021.

Timeline

7 February 2011

Primary endpoint
20 May 2021

20 May 2021

Quick facts

Lead sponsor	Foundation for Liver Research
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	196
Start date	7 February 2011
Primary completion	20 May 2021
Estimated completion	20 May 2021
Sites	3 locations across Netherlands

Drugs / interventions tested

Tacrolimus and Sirolimus — full drug profile →
Tacrolimus (TACROLIMUS) — full drug profile →

Conditions studied

Liver Disease — all drugs for Liver Disease →

Sponsor

Foundation for Liver Research

Who can join

Adults 18 to 70, any sex, with Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study we compare long term renal function in liver transplantation recipients treated with standard dose extended-release tacrolimus alone and recipients treated with a combination of low dose extended-release tacrolimus and low dose sirolimus. The hypothesis is that the patients treated with the combination have better long term renal function than the patients treated with standard dose tacrolimus alone.

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:

Other recruiting trials for Liver Disease

Currently open trials in the same condition.

NCT04014413 — Safety and Efficacy of Fecal Microbiota Transplantation · NA · recruiting
NCT02382822 — Copenhagen Comorbidity in HIV Infection Study · active not recruiting
NCT00001971 — Evaluation of Patients With Liver Disease · recruiting

Other Foundation for Liver Research trials

Trials by the same sponsor.

NCT03120195 — EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study · NA · completed
NCT02292745 — Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Ad · NA · completed
NCT01373684 — PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01958190 (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 Foundation for Liver Research
Last refreshed: 18 March 2022

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/NCT01958190.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing