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Completed

NCT Number: NCT00297765

Optimizing Prograf® Therapy in Renal Transplant Patients

A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.

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Key information

Conditions

Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, United States

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About this study

A 3 arm study (2 Active, 1 Active Control) to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient was 18 years of age at the time of transplant.
  • Patient is at least 6 months post-transplant.

Exclusion criteria

  • Patient is the recipient of a solid organ transplant other than the kidney.
  • Patient is a known carrier of any of the HIV viruses.

Treatment and study plan

Tacrolimus, Prograf®

Drug

Primary outcomes

  1. The effect of conversion from cyclosporine to Prograf-based therapy on renal function

    Time frame: 12 months

Secondary outcomes

  1. Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study title

OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)

Acronym: OPTIMA

Important dates

Study start
2003
Study completion
2006
First posted
Mar 1, 2006
Registry last updated
Aug 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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