Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation

NCT00807144 | Completed Phase 4 Results DMC

• 2 other identifiers: ICKTI08TX022008-000889-22
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The current anti-rejection drug regime for kidney transplant recipients in use at the West London Renal \& Transplant Centre (WLRaTC) consists of induction therapy with the very potent monoclonal antibody Campath 1-H (Alemtuzumab) followed by long-term maintenance with the Calcineurin inhibitor Tacrolimus The recent development (and licensing in the UK) of an extended-release, once daily formulation of Tacrolimus holds out the promise of simpler drug regimes for our patients. In the context of our current successful use of Tacrolimus monotherapy maintenance after Campath 1-H induction, the extended-release Tacrolimus formulation will enable us to offer a regime where the only long-term immunosuppressive treatment that most of our patients need will be a single drug, taken once a day. The investigators wish to assess the efficacy of such a regime in a structured comparison with our current protocol.

Conditions

End-stage Renal Failure; Graft Rejection

Keywords

Kidney transplant; Rejection; Adherence; Quality of life

Outcome Measures

Primary Outcomes (1)

• Patient Survival With a Functioning Graft

  One year post kidney transplantation

Secondary Outcomes (2)

• Rejection-free Patient Survival With a Functioning Graft

  One and two years post kidney transplantation

• Patient-reported Quality of Life, and Medication Adherence

  3,6,& 12 months post kidney transplant

Study Arms (2)

Prolonged-Release Tacrolimus

EXPERIMENTAL

Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy

Drug: Kidney transplant maintenance immunosuppression

Standard-Release tacrolimus

ACTIVE COMPARATOR

Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy

Drug: Tacrolimus (Kidney transplant maintenance immunosuppression)

Interventions

Tacrolimus (Kidney transplant maintenance immunosuppression) DRUG

Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml

Also known as: Prograf

Standard-Release tacrolimus

Kidney transplant maintenance immunosuppression DRUG

Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml

Also known as: Advagraf

Prolonged-Release Tacrolimus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Live donor kidney transplant recipients
• heart-beating-Deceased donor kidney transplant recipients
• Patients suitable for induction therapy with Alemtuzumab

You may not qualify if:

• Recipients of Non-heart-beating deceased donor kidney transplants
• Recipients of simultaneous kidney/pancreas transplants
• ABO incompatible/desensitized transplant recipients
• Positive flow cross-match/desensitized transplant recipients
• Patients with heavy prior exposure to myelosuppressive therapy
• Patients with previous malignancy
• Patients with HIV,Hepatitis-C, or Hepatitis-B infection

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

West London Renal & Transplant Centre, Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Related Links

• Conference abstract

MeSH Terms

Conditions

Kidney Failure, Chronic; Rejection, Psychology

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Adam McLean
• Organization: Imperial College Healthcare NHS Trust

adammclean@nhs.net

+44 020 8383 5164

Study Officials

• Adam G McLean, MA DPhil

  Imperial College Kidney & Transplant Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 27, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)