NCT00843856

Brief Summary

Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of membranous glomerulonephritis it is likely to improve the initial response to treatment and reduce the risk of relapse on stopping therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2009

Longer than P75 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

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

March 3, 2009

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 12, 2019

Completed
Last Updated

December 12, 2019

Status Verified

November 1, 2019

Enrollment Period

9 years

First QC Date

February 12, 2009

Results QC Date

September 12, 2019

Last Update Submit

November 21, 2019

Conditions

Glomerulonephritis, Membranous

Keywords

Glomerulonephritis

Outcome Measures

Primary Outcomes (1)

  • Number of Patient Who Gained Remission From the Nephrotic Syndrome

    Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy.

    10-109 weeks

Secondary Outcomes (1)

  • Number of Patients Achieved Remission

    6-12 months

Study Arms (2)

tacrolimus

ACTIVE COMPARATOR

Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L

Drug: tacrolimus

tacrolimus and mycophenolate mofetil

ACTIVE COMPARATOR

tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L

Drug: tacrolimus and mycophenolate mofetil

Interventions

tacrolimusDRUG

tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml

Also known as: prograff
tacrolimus
tacrolimus and mycophenolate mofetilDRUG

tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L

Also known as: prograf, cellcept
tacrolimus and mycophenolate mofetil

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic membranous glomerulonephritis on renal biopsy
  • Proteinuria - protein/creatinine ratio (PCR) \> 100 units with hypoalbuminaemia or PCR \> 300 units with normal serum albumin despite 3 months treatment with maximum tolerated doses of ace inhibitors and angiotensin 2 antagonists (or shorter if life threatening complications of nephrotic syndrome require institution of immediate immunosuppression)
  • Male or female patients aged 18 to 80 years

You may not qualify if:

  • Hepatitis B hepatitis C or HIV positive
  • Malignancy (all patients must have a CT chest abdomen and pelvis and other investigations if clinically indicated)
  • Untreated infection
  • Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
  • Any condition judged by the investigator that would cause the study to be detrimental to the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Hospital

London, W12 OHS, United Kingdom

Location

Related Publications (2)

  • Nikolopoulou A, Condon M, Turner-Stokes T, Cook HT, Duncan N, Galliford JW, Levy JB, Lightstone L, Pusey CD, Roufosse C, Cairns TD, Griffith ME. Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled trial. BMC Nephrol. 2019 Sep 6;20(1):352. doi: 10.1186/s12882-019-1539-z.

    PMID: 31492152RESULT

  • von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

    PMID: 34778952DERIVED

MeSH Terms

Conditions

Glomerulonephritis, MembranousGlomerulonephritis

Interventions

TacrolimusMycophenolic Acid

Condition Hierarchy (Ancestors)

NephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Results Point of Contact

Title
Dr Megan Griffith
Organization
Imperial College NHS Trust
megan.griffith1@nhs.net
02083835272

Study Officials

  • Megan Griffith, MBChB PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

March 3, 2009

Primary Completion

March 1, 2018

Study Completion

September 18, 2018

Last Updated

December 12, 2019

Results First Posted

December 12, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)