NCT00541814

Brief Summary

The purpose of this trial is to ascertain whether the withdrawal of calcineurin inhibitors (CNI) will lead to less kidney transplant damage when compared with minimisation. The investigators will assess this by comparing the degree of damage on kidney biopsies taken before and after minimisation/withdrawal of CNI.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

September 8, 2008

Status Verified

September 1, 2008

First QC Date

October 9, 2007

Last Update Submit

September 5, 2008

Conditions

Chronic Allograft Nephropathy

Keywords

Renal TransplantationCalcineurin InhibitorCyclosporineWithdrawalMinimisation

Outcome Measures

Primary Outcomes (1)

  • To compare renal allograft markers of damage and evolving injury in biopsies immediately pre study and at the end of the study

    16 months

Secondary Outcomes (6)

  • To compare markers of kidney transplant function

    16 months

  • To compare markers of immune function

    16 months

  • Infection episodes

    16 months

  • To assess changes in independent cardiovascular risk factors

    16 months

  • Malignancy

    16 months

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

CNI \[Cyclosporine\] minimisation Group. Conversion from azathioprine to Myfortic followed by a three month period of cyclosporine weaning to target blood level of 50-100 ng/ml.

Drug: Cyclosporine

2

EXPERIMENTAL

CNI \[Cyclosporine\] withdrawal Group. Conversion from azathioprine to Myfortic followed by a three month period of cyclosporine weaning to the point of withdrawal.

Drug: Cyclosporine

Interventions

CyclosporineDRUG

Target drug level 50-100 ng/ml or cyclosporine withdrawal

Also known as: Neoral
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be an adult recipient of a first kidney transplant
  • A functioning kidney allograft with estimated (e)GFR by MDRD \> 30 ml/min/1.73 m2, and be between 1 and 5 years post transplantation
  • Stable allograft function, as defined by no greater than 10% rise in serum creatinine in the preceding 6 months, on cyclosporine and azathioprine based immunosuppression
  • Minimal proteinuria, evidenced as urine albumin: creatinine ratio \< 50 mg/mmol

You may not qualify if:

  • \> = 18 years of age
  • Pregnancy or suspicion of pregnancy confirmed by positive b-HCG pregnancy test
  • Female patients unwilling to take effective contraception for study duration
  • Untreated ureteric obstruction on ultrasound of allograft
  • Recurrent urosepsis
  • Severe systemic infection
  • Untreated significant (\> 50%) renal artery stenosis on magnetic resonance angiography performed prior to study
  • History of acute allograft rejection
  • History of myocardial infarction
  • History of malignancy in previous 5 years (excluding non-melanomatous tumours limited to skin)
  • Symptomatic ischaemic heart disease
  • Hepatitis B surface antigen positive, Hepatitis C positive, or HIV positive
  • Recipient of combined organ transplantation (e.g. pancreas/kidney; liver/kidney)
  • Recipient of ABO-incompatible kidney
  • Greater than 1 HLA mismatch at either the "B" or "DR" locus
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

RECRUITING

Related Links

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Richard Borrows, MRCP

    University Hospital Birmingham NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Borrows, MRCP

CONTACT

00 44 1216275715richard.borrows@uhb.nhs.uk

Jason Moore, MRCP

CONTACT

00 44 1216275715j.moore.3@bham.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 9, 2007

First Posted

October 10, 2007

Study Start

October 1, 2007

Study Completion

February 1, 2010

Last Updated

September 8, 2008

Record last verified: 2008-09

Locations

GB(1)