CompletedPhase 4

Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients

France75 participantsStarted 2015-07

Plain-language summary

Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Recipients of a kidney transplant from a deceased donor or a living donor Exclusion Criteria: * Recipient of any transplanted organ other than a kidney; * Recipients of a bone marrow or stem cell transplant; * Recipients of a kidney from a cardiac death donor; * Recipients of a kidney from an ABO incompatible donor;

What they're measuring

Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL

Timeframe: pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hr post-dose

Trial details

NCT IDNCT02500212

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Organ or Tissue Transplant; Complications trials