Study Evaluating Conversion From Tacrolimus to Sirolimus in Stable Kidney Transplant Recipients Receiving Myfortic

NCT00713284 | Completed Phase 4 Results

• 1 other identifier: KTXP_US28_MYFIIRP07
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the combination of Myfortic and sirolimus is effective at preventing rejection while preserving kidney function in stable kidney transplant recipients.

Conditions

Renal Transplantation

Keywords

Kidney transplantation; Sirolimus; Immunosuppression; Tacrolimus

Outcome Measures

Primary Outcomes (1)

• Renal Allograft Function

  Renal allograft function will be assessed based on serum creatinine

  six months

Study Arms (1)

Study

OTHER

All subjects who enroll in this study will be converted from their calcineurin inhibitor to sirolimus. There is no comparotor arm

Drug: sirolimus

Interventions

sirolimus DRUG

Oral tablet(s) taken daily for 6 months; dose will be based on serum trough levels.

Also known as: Rapamune, rapamycin

Study

Eligibility Criteria

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

You may qualify if:

• Male or female patient 18 years of age or older.
• Patient has been fully informed of study procedures and requirements, has signed an IRB approved consent form and is willing and able to follow study procedures.

You may not qualify if:

• Patient has previously received an organ transplant.
• Patient has an identified donor specific antibody prior to transplant
• Patient is known to be seropositive for the human immunodeficiency virus (HIV).
• Patient has active Hepatitis C or B infection documented by a positive DNA PCR. Patients who are seropositive for Hepatitis C virus (HCV) or B virus (HBV) but have negative HCV-RNA or HBV-DNA by PCR may be included.
• Patient has a current malignancy or a history of malignancy within the past 5 years, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
• Patient has an uncontrolled infection or unstable medical condition that could interfere with the study objectives.
• Patient is currently taking or has been taking an investigational drug in the past 30 days.
• Patient has a known hypersensitivity to sirolimus or Myfortic®.
• Patient is pregnant or lactating.
• Patient is unlikely to comply with the visits scheduled in the protocol.
• Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
• Patient is 90 to 180 days after having received a primary living- or cadaver-donor renal allograft
• Patient has been maintained on a regimen of tacrolimus, Myfortic® and corticosteroids prior to study enrollment.
• Patient has a stable allograft defined as calculated GFR \> 30 mL/min using Nankivell equation.
• Patient has been fully informed of study procedures and requirements, has signed an IRB approved consent form and is willing and able to follow study requirements.

Sponsors & Collaborators

• California Pacific Medical Center Research Institute: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

California Pacific Medical Center; Barry S. Levin, MD Department of Transplantation

San Francisco, California, 94115, United States

Location

Related Publications (14)

• Merion RM, White DJ, Thiru S, Evans DB, Calne RY. Cyclosporine: five years' experience in cadaveric renal transplantation. N Engl J Med. 1984 Jan 19;310(3):148-54. doi: 10.1056/NEJM198401193100303.

  PMID: 6361559 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

• Nankivell BJ, Borrows RJ, Fung CL, O'Connell PJ, Allen RD, Chapman JR. The natural history of chronic allograft nephropathy. N Engl J Med. 2003 Dec 11;349(24):2326-33. doi: 10.1056/NEJMoa020009.

  PMID: 14668458 BACKGROUND

• Hariharan S, McBride MA, Cherikh WS, Tolleris CB, Bresnahan BA, Johnson CP. Post-transplant renal function in the first year predicts long-term kidney transplant survival. Kidney Int. 2002 Jul;62(1):311-8. doi: 10.1046/j.1523-1755.2002.00424.x.

  PMID: 12081593 BACKGROUND

• Oberbauer R, Segoloni G, Campistol JM, Kreis H, Mota A, Lawen J, Russ G, Grinyo JM, Stallone G, Hartmann A, Pinto JR, Chapman J, Burke JT, Brault Y, Neylan JF; Rapamune Maintenance Regimen Study Group. Early cyclosporine withdrawal from a sirolimus-based regimen results in better renal allograft survival and renal function at 48 months after transplantation. Transpl Int. 2005 Jan;18(1):22-8. doi: 10.1111/j.1432-2277.2004.00052.x.

  PMID: 15612979 BACKGROUND

• Flechner SM, Kurian SM, Solez K, Cook DJ, Burke JT, Rollin H, Hammond JA, Whisenant T, Lanigan CM, Head SR, Salomon DR. De novo kidney transplantation without use of calcineurin inhibitors preserves renal structure and function at two years. Am J Transplant. 2004 Nov;4(11):1776-85. doi: 10.1111/j.1600-6143.2004.00627.x.

  PMID: 15476476 BACKGROUND

• Stallone G, Di Paolo S, Schena A, Infante B, Grandaliano G, Battaglia M, Gesualdo L, Schena FP. Early withdrawal of cyclosporine A improves 1-year kidney graft structure and function in sirolimus-treated patients. Transplantation. 2003 Apr 15;75(7):998-1003. doi: 10.1097/01.TP.0000057240.95073.35.

  PMID: 12698087 BACKGROUND

• Mota A, Arias M, Taskinen EI, Paavonen T, Brault Y, Legendre C, Claesson K, Castagneto M, Campistol JM, Hutchison B, Burke JT, Yilmaz S, Hayry P, Neylan JF; Rapamune Maintenance Regimen Trial. Sirolimus-based therapy following early cyclosporine withdrawal provides significantly improved renal histology and function at 3 years. Am J Transplant. 2004 Jun;4(6):953-61. doi: 10.1111/j.1600-6143.2004.00446.x.

  PMID: 15147430 BACKGROUND

• Morales JM, Wramner L, Kreis H, Durand D, Campistol JM, Andres A, Arenas J, Negre E, Burke JT, Groth CG; Sirolimus European Renal Transplant Study Group. Sirolimus does not exhibit nephrotoxicity compared to cyclosporine in renal transplant recipients. Am J Transplant. 2002 May;2(5):436-42. doi: 10.1034/j.1600-6143.2002.20507.x.

  PMID: 12123209 BACKGROUND

• Reitamo S, Spuls P, Sassolas B, Lahfa M, Claudy A, Griffiths CE; Sirolimus European Psoriasis Study Group. Efficacy of sirolimus (rapamycin) administered concomitantly with a subtherapeutic dose of cyclosporin in the treatment of severe psoriasis: a randomized controlled trial. Br J Dermatol. 2001 Sep;145(3):438-45. doi: 10.1046/j.1365-2133.2001.04376.x.

  PMID: 11531834 BACKGROUND

• Flechner SM, Goldfarb D, Modlin C, Feng J, Krishnamurthi V, Mastroianni B, Savas K, Cook DJ, Novick AC. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation. 2002 Oct 27;74(8):1070-6. doi: 10.1097/00007890-200210270-00002.

  PMID: 12438948 BACKGROUND

• Simmons WD, Rayhill SC, Sollinger HW. Preliminary risk-benefit assessment of mycophenolate mofetil in transplant rejection. Drug Saf. 1997 Aug;17(2):75-92. doi: 10.2165/00002018-199717020-00001.

  PMID: 9285199 BACKGROUND

• Budde K, Curtis J, Knoll G, Chan L, Neumayer HH, Seifu Y, Hall M; ERL B302 Study Group. Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: results of a 1-year study. Am J Transplant. 2004 Feb;4(2):237-43. doi: 10.1046/j.1600-6143.2003.00321.x.

  PMID: 14974945 BACKGROUND

• Salvadori M, Holzer H, de Mattos A, Sollinger H, Arns W, Oppenheimer F, Maca J, Hall M; ERL B301 Study Groups. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am J Transplant. 2004 Feb;4(2):231-6. doi: 10.1046/j.1600-6143.2003.00337.x.

  PMID: 14974944 BACKGROUND

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Limitations and Caveats

Limitation is small sample size.

Results Point of Contact

• Title: Dr. V. Ram Peddi
• Organization: California Pacific Medical Center

peddir@sutterhealth.org

415-600-1000

Study Officials

• V. Ram Peddi, MD

  California Pacific Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 11, 2008
• Study Start: May 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 27, 2020
• Results First Posted: October 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)