Optima: Optimizing Prograf Therapy in Maintenance Allografts II

NCT00905515 | Completed Phase 4 Results

• 1 other identifier: MR-06-001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to optimize calcineurin immunosuppressive regimens and evaluate immunological and non-immunological markers that may explain mechanistic differences in these agents and their effects.

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; Immunosuppressive Agents

Outcome Measures

Primary Outcomes (3)

• Renal Function in Patients Converted From Cyclosporine to Prograf

  3 years

• Optimal Dose of Calcineurin Inhibitor in Long-term Maintenance Kidney Transplant Patients

  3 years

• Change in Risk Factors for Cardiovascular Morbidity and Chronic Graft Dysfunction as Evidenced by Blood Levels of Homocysteine

  3 years

Study Arms (3)

Control Group Cyclosporine

ACTIVE COMPARATOR

Maintain on Cyclosporine (CsA) at target trough level of 50-250 ng/mL.

Drug: cyclosporine

Low Trough Level Prograf Group

ACTIVE COMPARATOR

Convert to Prograf (TAC) at target trough levels of 3.0-5.9 ng/mL.

Drug: Prograf (Tacrolimus)

High Trough Level Prograf Group

ACTIVE COMPARATOR

Convert to TAC at target trough levels of 6.0-8.9 ng/mL.

Drug: Prograf (Tacrolimus)

Interventions

cyclosporine DRUG

Maintain on cyclosporine at target trough level of 50-250 ng/mL.

Also known as: Cyclosporine/Neoral®/Sandimmune®/Gengraf®

Control Group Cyclosporine

Prograf (Tacrolimus) DRUG

Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).

Also known as: Tacrolimus/Prograf®/FK506

High Trough Level Prograf Group; Low Trough Level Prograf Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is the recipient of a cadervic or living donor renal transplant.
• Patient was 18 years of age at time of transplant.
• Patient is at least 6 months post-transplant.
• Patient has been on a cyclosporine-based immunosuppressive regimen since the transplant.
• Patient has a functioning allograft and a Cockcroft/Gault estimate of creatinine clearance \>or= 35 mL/min within four weeks prior to randomization.
• Patient or legal guardian has signed and dated an Institutional Review Board (IRB) approved informed consent document and is willing and able to follow study procedures.
• Females are not pregnant and agree to practice effective birth control while receiving immunosuppressant medication.

You may not qualify if:

• Patient is the recipient of a solid organ transplant other than the kidney.
• Patient experienced biopsy-confirmed, acute rejection, (Banff 97 criteria)within 3 months before randomization that required treatment, which is defined as antilymphocyte therapy, corticosteroids, or an increase in the number or dose of immunosuppressant medication.
• Patient has recurrence of primary renal disease, or de novo renal disease.
• Patient has a urine protein of \> 1.5g/24 hours or two successive urinalyses sent to and reported by the laboratory indicating albuminuria greater than 2+ within 6 months prior to enrollment.
• Patient has an estimated creatinine clearance \< 35 mL/min calculated using Cockcroft/Gault formula within four weeks prior to randomization.
• Patient has changed adjunctive immunosuppressant therapy within one month if randomization.
• Patient is pregnant or lactating.
• Patient is a known carrier of any of the HIV viruses.
• Patient has a known or suspected malignancy (except for treated squamous or basal cell skin cancers) \< 5 years before randomization or a history of post-transplant lymphoproliferative disease (PTLD).
• Patient has a known hypersensitivity to tacrolimus, or any of the excipients of the drug.

Sponsors & Collaborators

• East Carolina University: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Brody School of Medicine at East Carolina University

Greenville, North Carolina, 27834, United States

Location

Related Publications (2)

• Dharnidharka VR, Kwon C, Stevens G. Serum cystatin C is superior to serum creatinine as a marker of kidney function: a meta-analysis. Am J Kidney Dis. 2002 Aug;40(2):221-6. doi: 10.1053/ajkd.2002.34487.

  PMID: 12148093 BACKGROUND

• Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group. Transplantation. 1997 Apr 15;63(7):977-83. doi: 10.1097/00007890-199704150-00013.

  PMID: 9112351 BACKGROUND

MeSH Terms

Interventions

Cyclosporine; Tacrolimus

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: East Carolina University

bryantw@ecu.edu

252-744-0671

Study Officials

• Paul Bolin, MD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Internal Medicine

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: August 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 7, 2023
• Results First Posted: February 11, 2013

Record last verified: 2023-09

Locations

US (1)