Ignite Creation Date:
2024-05-06 @ 2:01 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01955187
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2013-09-19
Brief Title:
Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous Nephropathy
Sponsor:
Hospital Universitario 12 de Octubre
Organization:
Hospital Universitario 12 de Octubre
Study Overview
Official Title:
European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy The STARMEN Study
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARMEN
Brief Summary:
In this study investigators will evaluated the long-term efficacy and safety two years of Tacrolimus-Rituximab RTX therapy compared to Methylprednisolone-Cyclophosphamide CYC therapy in patients with primary Membranous Nephropathy MN
PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus leads to a greater increase in the proportion of primary MN patients with Complete or Partial Remission when compared with patients receiving standard treatment It will be assessed 24 months after the beginning of treatment
Phase of the trial and design Phase III study open label randomized and active controlled trial
This study will have 3 stages screening and recruitment of patients for 18 months treatment period for six months in corticosteroids plus CYC group and 9 months in Tacrolimus-RTX group and finally post-treatment follow-up period until to complete 24 months of follow-up since initial treatment
This study will compare the standard therapy for primary MN patients with nephrotic range proteinuria active control of steroids plus CYC with a novel sequential therapy of tacrolimus and RTX an approach of potential high efficacy low toxicity and more acceptable safety profile
PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus leads to a greater increase in the proportion of primary MN patients with Complete or Partial Remission when compared with patients receiving standard treatment It will be assessed 24 months after the beginning of treatment
Phase of the trial and design Phase III study open label randomized and active controlled trial
This study will have 3 stages screening and recruitment of patients for 18 months treatment period for six months in corticosteroids plus CYC group and 9 months in Tacrolimus-RTX group and finally post-treatment follow-up period until to complete 24 months of follow-up since initial treatment
This study will compare the standard therapy for primary MN patients with nephrotic range proteinuria active control of steroids plus CYC with a novel sequential therapy of tacrolimus and RTX an approach of potential high efficacy low toxicity and more acceptable safety profile
Detailed Description:
PRIMARY AND SECONDARY ENDPOINTSOUTCOME MEASURES
Primary end-point
The proportion of patients reaching CR defined as a reduction of proteinuria since baseline level to a value equal or lower than 05 g24 h proteinuria plus stable renal function eGFR 45 mlmin173m2 or PR defined as a reduction of proteinuria since baseline level to a value less than 35 g24 h and 50 lower than baseline proteinuria plus stable renal function eGFR 45mlmin173m2 at 24 months of study treatment
Secondary end-points
The proportion of patients with Limited response LR defined as a reduction of proteinuria since baseline level 50 but to a value 35g24 h at 12 18 and 24 months of study treatment
The number of patients with an increase 50 of serum creatinine SCr from baseline at 12 18 and 24 months end of the follow-up
The time of renal survival status free of increase 50 of baseline SCr in both arms overall after the study
The proportion of patients with preserved renal function estimated GFR 60 mlmin in both treatment arms after the treatment period
The proportion of patients with relapse defines as the reappearance of proteinuria 35 gr24h and at least 50 increase over the lowest baseline value in at least three consecutive visits in those patients who previously presented a PR or CR and the time to relapse after the treatment period
Serum levels of anti-phospholipase A2 receptor antibodies anti-PLA2R before of treatment and at 3 6 9 12 18 and 24 months of study in both treatment arms
The proportion of patient with drug-related adverse events and serious adverse events
STUDY POPULATION
Patients with biopsy-proven idiopathic or primary membranous nephropathy with nephrotic proteinuria and normal or slight decrease of renal function will be enrolled
Primary end-point
The proportion of patients reaching CR defined as a reduction of proteinuria since baseline level to a value equal or lower than 05 g24 h proteinuria plus stable renal function eGFR 45 mlmin173m2 or PR defined as a reduction of proteinuria since baseline level to a value less than 35 g24 h and 50 lower than baseline proteinuria plus stable renal function eGFR 45mlmin173m2 at 24 months of study treatment
Secondary end-points
The proportion of patients with Limited response LR defined as a reduction of proteinuria since baseline level 50 but to a value 35g24 h at 12 18 and 24 months of study treatment
The number of patients with an increase 50 of serum creatinine SCr from baseline at 12 18 and 24 months end of the follow-up
The time of renal survival status free of increase 50 of baseline SCr in both arms overall after the study
The proportion of patients with preserved renal function estimated GFR 60 mlmin in both treatment arms after the treatment period
The proportion of patients with relapse defines as the reappearance of proteinuria 35 gr24h and at least 50 increase over the lowest baseline value in at least three consecutive visits in those patients who previously presented a PR or CR and the time to relapse after the treatment period
Serum levels of anti-phospholipase A2 receptor antibodies anti-PLA2R before of treatment and at 3 6 9 12 18 and 24 months of study in both treatment arms
The proportion of patient with drug-related adverse events and serious adverse events
STUDY POPULATION
Patients with biopsy-proven idiopathic or primary membranous nephropathy with nephrotic proteinuria and normal or slight decrease of renal function will be enrolled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-000226-55 | EUDRACT_NUMBER | None | None |