| CTRI Number |
CTRI/2024/02/062982 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effectiveness and safety of daily steroid plus cyclophosphamide versus alternate monthly steroid and cyclophosphamide in adults with membranous nephropathy with nephrotic syndrome |
|
Scientific Title of Study
|
Efficacy and safety of daily oral steroid and cyclophosphamide versus cyclical steroid and cyclophosphamide in adult nephrotic syndrome patients with membranous nephropathy :A Randomized Controlled Trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Paromita Das |
| Designation |
DM Resident, Nephrology |
| Affiliation |
All India Institute of Medical sciences, Bhubaneswar |
| Address |
Room No- 237, Second Floor, Department of Nephrology, All India Institute of Medical Sciences, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9874988733 |
| Fax |
|
| Email |
paromita.05.das@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Sandip Panda |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical sciences, Bhubaneswar |
| Address |
Room 247, Second floor, Department of Nephrology, All India Institute of Medical Sciences, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9626801175 |
| Fax |
|
| Email |
nephro_sandip@aiimsbhubaneswar.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Paromita Das |
| Designation |
DM Resident, Nephrology |
| Affiliation |
All India Institute of Medical sciences, Bhubaneswar |
| Address |
Room No- 237, Second Floor, Department of Nephrology, All India Institute of Medical Sciences, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9874988733 |
| Fax |
|
| Email |
paromita.05.das@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Department of Nephrology |
| Address |
Room 247, Second floor, Department of Nephrology, AIIMS Bhubaneswar |
| 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 |
| Dr Paromita Das |
AIIMS, Bhubaneswar |
Department of Nephrology
AIIMS, Bhubaneswar
Sijua
Patrapada
Odisha 751019 Khordha ORISSA |
9874988733
paromita.05.das@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
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 |
prednisolone and cyclophosphamide |
Oral prednisolone (0.5 mg/kg/day)for three months followed by tapering over next three months by 5 mg every two weeks (total steroid duration-6months)
Tablet Cyclophosphamide 2mg/kg per oral, daily, for 3 months |
| Comparator Agent |
Steroid and cyclophosphamide |
Month 1,3,5- Injection Methylprednisolone 1000 mg intravenously once daily for three days, followed by oral prednisolone 0.5 mg/kg/day for next 27 days.
Month 2,4,6- Tablet cyclophosphamide 2mg/kg/day for 30 days.
Total duration of treatemnt- 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 to 80 years with nephrotic syndrome
2.Membranous nephropathy diagnosed by renal biopsy
3.Patients classified as moderate risk, high risk or very risk as defined by KDIGO 2021 guidelines for membranous nephropathy
4.Estimated GFR more than 30 ml/min/1.73m2 of body surface area, as calculated using CKD-EPI formula
5.In females, has to be practicing medically approved method of contraception, or surgically sterile or post-menopausal
|
|
| ExclusionCriteria |
| Details |
1. Secondary causes of membranous nephropathy will be excluded (SLE, medications like NSAIDs, COX-2 inhibitors, malignancy)
2. Active underlying infection, including but not limited to hepatitis B, hepatitis C, HIV
3. Pregnant or breast-feeding women
4. Allergy or hypersensitivity to cyclophosphamide (oral or intravenous)
5. Immunosuppressant intake in the 6 months prior to enrolment
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the remission rate (complete or partial) at 6 months in patients treated with daily oral steroid plus cyclophosphamide versus cyclical steroid and cyclophosphamide therapy |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare proportion of patients with relapse in both treatment groups at 12 and 24 months.
2.To compare renal survival (patients not having more than 50% decline from baseline eGFR or not developing ESRD) and patient survival in both groups at 12 and 24 months.
3.To compare adverse events in both treatment groups.
|
6 months, 12 months and 24 months |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/02/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Membranous Nephropathy is the most common cause of nephrotic syndrome in adults. The oldest and most widely accepted treatment is alternate monthly steroid and cyclophosphamide, also known as the modified Ponticelli regimen. This regimen requires hospitalisation for three days for administration of intravenous steroid in the first, which is then followed by oral steroids for the remaining 27 days. This schedule is followed in the first, third, fifth month. In the second, fourth and sixth month patient is given oral cyclophosphamide. This regimen requires a fair degree of patient understanding and compliance, and also the need for hospitalisation. There has been no study till date evaluating a completely oral regimen for treatment of membranous nephropathy. An oral regimen where cycplophosphamide and steroid is administered daily for three months, followed by only steroid for the remaining three months, will be easier for the patient to follow. It will not require hospitalisation and can ensure patient compliance. In this regimen, the total cumulative dose of steroid will be lower. So our study attempts to evaluate both efficacy and safety of the oral regimen to the already established treatment of alternate cyclical steroid and cyclophosphamide in the treatment of adult nephrotic syndrome patients with membranous nephropathy. |