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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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10 December 2019 |
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Main ID: |
EUCTR2009-016003-26-GB |
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Date of registration:
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17/03/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic
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Scientific title:
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RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic |
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Date of first enrolment:
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06/05/2010 |
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Target sample size:
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100 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016003-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
. Inclusion Criteria
1. Patients with new onset biopsy proven (within last year) primary FSGS with albumin lss than the normal laboratory reference range OR patients with primary IgAN with biopsy findings E1 or M1 using the Oxford classification (see Appendix 2) and a minimum of 8 glomeruli in the biopsy
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2. Proteinuria (Protein Creatinine Ratio, PCR>100mg/mmol or ACR>66mg/mmol) following at least 4 weeks treatment with maximal blood pressure lowering therapy (to include angiotensin blockade) to target blood pressure <130/80 mmHg
3. If female and of childbearing potential, must:
• Not be pregnant or breastfeeding
• Agree to avoid pregnancy during and for 6 weeks following the last dose of study treatment
4. If male with a partner of childbearing potential, must:
• Agree to use adequate, medically approved, contraceptive precautions during and for 6 weeks following the last dose of study treatment
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Exclusion criteria:
1. Age <18 years
2. Secondary causes of FSGS
3. Secondary IgAN
4. Deteriorating renal function >20µmol/l each week for 3 weeks or more
5. estimated Glomerular Filtration Rate (eGFR) <20 ml/min (using modification of diet in renal disease (MDRD) equation)
6. Poor blood pressure control (e.g. blood pressure =140/90 mmHg)
7. Previous treatment with immunosuppression therapies for renal disease
8. Unable to receive immunosuppression treatments due to malignancy or active infection
9. Patients with systemic infection unless specific anti-infective therapy is employed
10. Diabetes
11. Known to have Hepatitis B or C
12. Known to be HIV positive
13. Neutropenia
14. Inability to give informed consent
15. Greater than 2 weeks of steroid therapy for renal disease
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Primary Proteinuric Glomeruolnephritis
Focal segmental glomeruloscerosis and IgA nephropathy
MedDRA version: 14.1
Level: PT
Classification code 10067757
Term: Focal segmental glomerulosclerosis
System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1
Level: PT
Classification code 10021263
Term: IgA nephropathy
System Organ Class: 10038359 - Renal and urinary disorders
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Intervention(s)
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Trade Name: Myfortic
Product Name: Myfortic 360mg Tablets
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: mycophenolic acid
CAS Number: 24280-93-1
Other descriptive name: mycophenolate sodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 360-
Trade Name: Myfortic
Product Name: Myfortic 180mg Tablets
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: mycophenolic sodium
CAS Number: 24280-93-1
Other descriptive name: mycophenolate sodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 180-
Product Name: Prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 1.0-25.0
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Primary Outcome(s)
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Primary end point(s): The primary measure of efficacy will be the proportion of patients achieving complete or partial remission by 24 weeks sustained (relapse free) for 12 months.
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Main Objective: To determine the feasibility of running a full-scale randomised phase 3 trial of Myfortic plus short course steroids (prednisolone) versus standard care in patients with Focal segmental glomerulosclerosis (FSGS) or IgA nephropathy and to obtain preliminary comparative data on the efficacy of Myfortic plus short course steroids in inducing sustained response in patients with FSGS or IgAN.
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Secondary Objective: To determine preliminary data on the effectiveness of myfortic plus short course steroids in inducing sustained remission, reducing proteinuria and preventing progression of chronic kidney disease.
To determine treatment safety.
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Secondary ID(s)
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ISRCTN11937028
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1.0
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Completed:
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