| CTRI Number |
CTRI/2018/10/015976 [Registered on: 10/10/2018] Trial Registered Prospectively |
| Last Modified On: |
09/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Rituximab and Tacrolimus drugs in primary membranous nephropathy |
|
Scientific Title of Study
|
Open label randomized controlled study comparing rituximab and tacrolimus in treatment of primary membranous nephropathy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aneesh Nanda |
| Designation |
PDT Nephrology |
| Affiliation |
IPGMER, SSKM hospital, kolkata |
| Address |
Department of Nephrology
Chest and Cancer Block, 5th floor
IPGMER, SSKM HOSPITAL
244 AJC BOSE Road
Kolkata
WEST BENGAL
700020
India |
| Phone |
8728951509 |
| Fax |
|
| Email |
aneeshnanda@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debabrata Sen |
| Designation |
Professor, Dept Of Nephrology |
| Affiliation |
IPGMER, SSKM hospital, kolkata |
| Address |
Department of Nephrology
Chest and Cancer Block, 5th floor
IPGMER, SSKM HOSPITAL
244 AJC BOSE Road
Kolkata
WEST BENGAL
700020
India |
| Phone |
8728951509 |
| Fax |
|
| Email |
sendebabrata58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aneesh Nanda |
| Designation |
PDT Nephrology |
| Affiliation |
IPGMER, SSKM hospital, kolkata |
| Address |
Department of Nephrology
Chest and Cancer Block, 5th floor
IPGMER, SSKM HOSPITAL
244 AJC BOSE Road
Kolkata
WEST BENGAL
700020
India |
| Phone |
8728951509 |
| Fax |
|
| Email |
aneeshnanda@hotmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER, SSKM hospital
244 AJC Bose road
kolkata 700020 |
|
|
Primary Sponsor
|
| Name |
IPGMER SSKM hospital |
| Address |
IPGMER, SSKM hospital
244 AJC bose road
kolkata 700020 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aneesh Nanda |
IPGMER, SSKM hospital |
Department Of Nephrology
5th floor, Chest and Cancer block
244 AJC BOSE Road
Kolkata 700020
Kolkata
WEST BENGAL |
8728951509
aneeshnanda@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N042||Nephrotic syndrome with diffuse membranous glomerulonephritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
rituximab drug |
one arm consists of drug rituximab given at dose of 375 mg/m2 iv weekly for 4 doses only |
| Comparator Agent |
tab tacrolimus |
second arm consist of patient on tab tacrolimus at dose of 0.075 mg/kg/day divided in two doses 12 hr interval for 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Biopsy proven PMN of age group 18-70 years,
2. Fulfilling the criteria for initiation of immunosuppression- Urinary protein excretion persistently exceeds4 g/d AND remains at over 50% of the baseline value, AND does not show progressive decline, during antihypertensive and antiproteinuric therapy during an observation period of at least 6 months or Severe disabling or life threatening symptoms related to the nephrotic syndrome.
3. SCr has risen by 30% or more within 6 to 12 months from the time of diagnosis but the eGFR is not less than 25–30 ml/min per 1.73m2 AND this change is not explained by superimposed complications.
|
|
| ExclusionCriteria |
| Details |
1. Patients with active infection.
2. Diabetes mellitus.
3. Hepatitis B/C or human immunodeficiency virus infection.
4. Superimposed any other liver disease.
5. Neoplasia.
6. Chronic Diarrhoea.
7. Pregnancy.
8. Patients not willing for contraception.
9. Previous therapy with Prednisolone, MMF,CSA within 4 months and alkylating agents within 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The number of patients who will experience remission both partial and complete remission on the basis of urine protein analysis. |
The duration of follow-up will be at least 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Estimated glomerular filtration rate (eGFR) at the completion of therapy
b) Change in 24 hour urinary protein
c) Change in Sr albumin level
d) Time required for complete or partial remission
e) Adverse effects (leukopenia, impaired glucose tolerance (IGT)/diabetes mellitus, diarrhoea, new onset hypertension and impaired fasting lipid profile, infection).
|
at least 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims and Objectives of
the Study:
Aim: To compare the safety and efficacy of intravenous
rituximab with tacrolimus in the management of primary membranous nephropathy
Objectives:
•
Compare the efficacy of
rituximab and tacrolimus in achievement of remission in primary membranous nephropathy.
•
Compare the percentage
of change of proteinuria in response to rituximab and tacrolimus.
•
Compare the side effect
profile and tolerability of rituximab
and tacrolimus in primary membranous
nephropathy.
Materials and Methods:
Study Area: The study will be a single center study
to be conducted in the Department of Nephrology, IPGME& R and SSKM
Hospital.
Study design:This will
be a Prospective open label randomized parallel group interventional study
Method of randomization: Random number table
Study
population: All primary
membranous nephropathy patients admitted in the Department of Nephrology, those attending OPD services and
those referred to this department from other hospitals will constitute the
study population.
|