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Clinical Trials/EUCTR2008-003240-11-FR
EUCTR2008-003240-11-FR
Active, not recruiting
Phase 1

A Phase 3, Open-label, Multicenter, Prospective, Randomized Study of the Efficacy and Safety of Conversion from Prograf® Capsules Twice Daily to LCP-Tacro™ Tablets Once Daily for the Prevention of Acute Allograft Rejection in Stable Kidney Transplant Patients

ifeCycle Pharma A/S0 sites302 target enrollmentMarch 17, 2009
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ConditionsCP-Tacro tablets will be investigated for immunosuppression for the prevention of acute allograft rejection in adult renal transplant patients.MedDRA version: 9.1Level: LLTClassification code 10048870Term: Prophylaxis against transplant rejection
DrugsPrograf 0.5 mg hard capsules

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
CP-Tacro tablets will be investigated for immunosuppression for the prevention of acute allograft rejection in adult renal transplant patients.
Sponsor
ifeCycle Pharma A/S
Enrollment
302
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 17, 2009
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ifeCycle Pharma A/S

Eligibility Criteria

Inclusion Criteria

  • •Men and women at least 18 years of age who are recipients of a kidney transplant between 3 months and 5 years before the screening date.
  • •Patients taking oral Prograf capsules twice daily, a least 2 mg total dose per day, as part of their maintenance immunosuppression therapy, with tacrolimus trough levels of 5 to 15 ng/mL. Patients must maintain tacrolimus trough levels in this range during the 7\-day Run\-in Period to be eligible for randomization (based on two consecutive trough level measurements at least 48 hours apart.
  • •Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before receiving study drug
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Recipients of any transplanted organ other than kidney
  • •Recipients of a bone marrow transplant
  • •Patients with an eGFR (MDRD7\) \< 30 mL/min at Screening
  • •Patients with a spot protein:creatinine ratio \> 0\.5
  • •Patients with a white blood cell (WBC) count \= 2\.8 × 10^9/L unless the WBC count has been stable for at least 2 weeks and the absolute neutrophil count is \> 1\.0 × 10^9 /L
  • •Patients unable to swallow study medication
  • •Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent and who are unwilling or unable to comply with the study protocol requirements
  • •Pregnant or nursing women
  • •Patients with reproductive potential who are unwilling/unable to use a double\-barrier method of contraception
  • •Patients who were treated with any other investigational agent within 3 months before Screening

Outcomes

Primary Outcomes

Not specified

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