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Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetil based Immunosuppression in De novo Kidney Transplant Recipients using extensive pharmacokinetics monitoring

Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetil based Immunosuppression in De novo Kidney Transplant Recipients using extensive pharmacokinetics monitoring - Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetil based Immunosuppression

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033089
Enrollment
60
Registered
2018-06-30
Start date
2012-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease patients to whom kidney transplantation is planned

Interventions

Standard group Target tacrolimus AUC 0-24 hr 1) til 1 month after transplant 250ng x hr/ml 2) 1 month - 3 months after transplant 200-250 ng x hr/ml 3) 3 months thereafter transplant

Sponsors

Department of Transplant Surgery Kidney Disease Center Nagoya Daini Red Cross Hospital
Lead Sponsor
Kumamoto Red Cross Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) ABO compatible or mismatch kideny transplant recipient. 2) de novo kidney transplant recipient from non-HLA identical living renal donor. 3) Recipient who can be resposible for the written consents. 4) Women who is no pregnent.

Exclusion criteria

Exclusion criteria: 1) Multiple organ recipient or previous transplant history. 2) HLA identical living related donor. 3) ABO incompatible or T cell CDC-crossmatch positive case. 4) HIV, HCV, HBsAb positive recipients.

Design outcomes

Primary

MeasureTime frame
Biopsy-proven acute allograft rejection rate after 6 months and 12 months.

Secondary

MeasureTime frame
1) Patient survival rate, Allograft survival rate 2) Incidence of viral infection 3)Incidence rate of de novo donor specific antibody production.

Countries

Japan

Contacts

Public ContactYoshihiko Watarai

Nagoya Daini Red Cross Hospital Transplant Surgery

watarai@nagoya2.jrc.or.jp052-832-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026