| CTRI Number |
CTRI/2025/10/096097 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the benefits and safety of low dose multidrug combination immunosuppressive therapy in patients of primary membranous nephropathy with nephrotic syndrome |
|
Scientific Title of Study
|
A prospective observational study to assess the efficacy and safety of low dose corticosteroids, cyclophosphamide and rituximab in patients with primary membranous nephropathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Prabhahar |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER |
| Address |
Department of Nephrology, Nehru Hospital, Postgraduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087266534 |
| Fax |
|
| Email |
arunprabhaharcmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raja Ramachandran |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Department of Nephrology, Nehru Hospital, Postgraduate Institute of Medical Education and Research
CHANDIGARH
160012
India |
| Phone |
9216958874 |
| Fax |
|
| Email |
drraja1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Prabhahar |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER |
| Address |
Department of Nephrology, Nehru Hospital, Postgraduate Institute of Medical Education and Research
CHANDIGARH
160012
India |
| Phone |
7087266534 |
| Fax |
|
| Email |
arunprabhaharcmc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER, Chandigarh |
| Address |
Postgraduate Institute of Medical Education and Research, Madhya Marg, Sector 12, Chandigarh-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Indranil Ghosh |
Army Hospital (Research and Referral), New Delhi |
Army Hospital (Research and Referral), Delhi Cantt, New Delhi, Delhi-110010
South West
DELHI |
9876268895
mili2912@gmail.com |
| Arun Prabhahar |
Postgraduate Institute of Medical Education and Research, Chandigarh |
PGIMER, Sector 12, Madhya Marg, Chandigarh-160012
Chandigarh
CHANDIGARH |
7087266534
arunprabhaharcmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Army Hospital Research and Referral Ethics Committee |
Submittted/Under Review |
| Postgraduate Institute of Medical Education and Research, Chandigarh-Institutional Ethics Committee (Intramural) |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than or equal to 18 years
2. Biopsy proven cases of MN
3. Treatment naïve and relapsing cases of MN
4. Proteinuria or protein creatinine ratio (PCR) more than or equal to 3.5 g/24h despite supportive treatment
for at least 6 months
5. Serum albumin less than 30 g/L 6. eGFR more than or equal to 40 ml/min/1.73m2 at enrolment
6. Earlier treatment with immunosuppression is warranted, as determined by the treating
physician. |
|
| ExclusionCriteria |
| Details |
1. Previously received immunosuppression in past
2. Patients with active infection
3. Secondary Membranous Nephropathy
4. Biopsy suggestive of co-existent diabetic nephropathy in diabetic patients
5. Patients with uncontrolled diabetes, liver failure, heart failure
6. Kidney transplant recipients
7. Pregnancy
8. Suspected or known allergy to any of the drugs used in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective measure is an endpoint comprising efficacy, defined as either
complete remission (CR) or partial remission (PR). |
3,6,12,18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse events: is Count of serious adverse events (SAE) or nonserious adverse events
of special interests (NSAESI) |
3,6,12,18 MONTHS |
| Immunological remission (anti-PLA2R positive participants) |
|
| Quality of life (36-Item Short Form Survey Instrument Questionnaire: SF-36) |
|
|
|
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)
|
01/11/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [arunprabhaharcmc@gmail.com].
- For how long will this data be available start date provided 01-11-2025 and end date provided 01-11-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - None
|
|
Brief Summary
|
Despite immunosuppressive therapy, one third of patients with Primary Membranous Nephropathy (PMN) progress to kidney failure, requiring dialysis or transplantation. The standard treatment—cyclical corticosteroid and cyclophosphamide—is effective but toxic, and rituximab fails in 40% of cases. Thus, safer, equally effective alternatives are needed. Novelty: This pilot study has been planned to assess the combination of low-dose corticosteroid and cyclophosphamide, and rituximab in primary MN. It also enables subgroup analyses based on clinical variables such as proteinuria, serum albumin, and anti-PLA2R titre. Objective: To study the efficacy of low-dose corticosteroid and cyclophosphamide and rituximab PMN, assessing the response rates, adverse events, and quality of life (QOL). Methodology: This trial is a prospective multi-centre observational study planned to be conducted at Department of Nephrology, PGIMER, Chandigarh, and Department of Nephrology, Army Hospital (Research and Referral), New Delhi. Eligible participants (adults more than or equal to 18 years of age) will receive low-dose corticosteroid, cyclophosphamide, and rituximab. Patients will be followed up for a period of 18 months to study the efficacy in achieving clinical and immunological remission, adverse event profile, and QOL. Primary Outcome: The primary endpoint comprises response in the form of efficacy—complete or partial remission. Secondary Outcome: (a)To estimate Adverse events: Count of serious adverse events (SAE) or nonserious adverse events of special interest (NSAESI), (b)Immunological remission (anti-PLA2R positive participants), (c)Quality of life (36-Item Short Form Survey Instrument Questionnaire: SF-36) |