NCT01860183

Brief Summary

Development of chronic changes (scarring) in transplanted kidney tissue is a major cause of long-term kidney function deterioration and ultimately graft loss. It results from both immunologic and non-immunologic mechanisms. Mycophenolate mofetil (MMF) is immunosuppressive drug used for prevention of rejection after kidney transplant, usually in combination with a calcineurin inhibitor (tacrolimus or cyclosporine), with or without corticosteroids. Besides immunosuppression, MMF may also have direct antifibrotic properties. Tacrolimus has potent immunosuppressive effects and is the cornerstone of contemporary posttransplant immunosuppressive therapy in kidney recipients. However, it is also nephrotoxic. The hypothesis of the present study is that in the setting of similar net immunosuppression, higher dose of MMF (3 g daily) will result in slower progression of kidney fibrosis during first year posttransplant as compared to MMF 2 g daily. To test this hypothesis, the present study will randomly assign low immunological risk kidney transplant recipients to either 2g or 3 g MMF daily, in combination with tacrolimus, with, or without maintenance steroids. All patients will have kidney biopsy at implantation and at 12 months after transplantation. Main outcome will be 1-year change in chronic kidney histology (interstitial fibrosis) assessed by protocol biopsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 26, 2021

Status Verified

January 1, 2014

Enrollment Period

3.1 years

First QC Date

May 18, 2013

Last Update Submit

October 18, 2021

Conditions

Kidney TransplantationKidney Failure

Keywords

kidney transplantationchronic allograft dysfunctionmycophenolate mofetilChronic

Outcome Measures

Primary Outcomes (1)

  • Progression of interstitial fibrosis (ci)

    1 year

Secondary Outcomes (5)

  • Estimated glomerular filtration rate

    1 year

  • Time to first acute rejection episode

    up to 1 year

  • Progression of other chronic scores

    1 year

  • Graft loss

    1 year

  • Patient survival

    1 year

Other Outcomes (6)

  • Frequency of infections requiring hospitalization

    1 year

  • Frequency of CMV viremia

    1 year

  • Frequency of BK viremia

    1 year

  • +3 more other outcomes

Study Arms (2)

MMF 3g daily

EXPERIMENTAL
Drug: Mycophenolate mofetil

MMF 2 g daily

ACTIVE COMPARATOR
Drug: Mycophenolate mofetil

Interventions

Mycophenolate mofetilDRUG

Mycophenolate will be administered to all study patients at dose of 3 g daily for the first seven days posttransplant. Afterwards, study patients will continue, as randomized, on either 3 g, or 2 g MMF daily.

MMF 2 g dailyMMF 3g daily

Eligibility Criteria

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

You may qualify if:

  • first kidney or kidney-pancreas transplantation
  • CDC PRA \<=20%

You may not qualify if:

  • dual kidney transplantation
  • AB0 incompatible transplantation
  • biopsy ci, ct, cv, or ah score \>=2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital Merkur

Zagreb, HR, 10000, Croatia

Location

Related Publications (1)

  • Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.

    PMID: 39382091DERIVED

MeSH Terms

Conditions

Renal InsufficiencyBronchiolitis Obliterans Syndrome

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

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

May 18, 2013

First Posted

May 22, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 26, 2021

Record last verified: 2014-01

Locations

CR(1)