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CTRI Number  CTRI/2025/10/096741 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Urine Immune Cells as Markers of kidney Health in Untreated Lupus Nephritis 
Scientific Title of Study   Clinical Outcomes Association and Extended Panel Urinary Lymphocyte Subset among Treatment-Naive Patients Diagnosed with Proliferative Lupus Nephritis: A Prospective Observational Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dharshan Rangaswamy 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal. 
Address  Room no.15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9901970787  
Fax    
Email  dharshan.r@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Prajna Angeline D Souza 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal. 
Address  Room no.15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  7022737001  
Fax    
Email  prajna.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dharshan Rangaswamy 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal. 
Address  Room no.15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9901970787  
Fax    
Email  dharshan.r@manipal.edu  
 
Source of Monetary or Material Support  
MAHE IMF Fund (Intramural), Manipal Academy of Higher Education (MAHE), Manipal- 576104, Karnataka, India. 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education (MAHE), Manipal. 
Address  Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka, India - 576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dharshan Rangaswamy  Kasturba Medical College and Kasturba Hospital, Manipal, MAHE, Manipal.  Room no.15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA 		 9901970787

dharshan.r@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committiee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M321||Systemic lupus erythematosus withorgan or system involvement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  30 newly diagnosed LN patients with renal biopsy-proven Class II, IV, or combination class with Class V lesions on renal histology, willing to provide informed consent to participate in the study.
15 newly diagnosed SLE patients without renal involvement as Disease Controls (DC). Absence of renal involvement is defined as,
i. Urine RBCs: lesser than 2/ HPF
ii. Random UpCr: lesser than 0.3mg/mg or 24hr-urine protein lesser than 300mg/ day
iii. Serum creatinine: lesser than 1.l mg/dL
SLE patients on a corticosteroid dose equivalent or less than 0.2mg/kg/day of prednisolone in the last one month.
Patients previously treated with immunosuppressants such as mycophenolate mofetil (MMF) or cyclophosphamide may be included only if a minimum of:
3 months have passed since the last dose of MME, and 12 months since the last dose of
cyclophosphamide, and the patient demonstrates clinical stability with no recent flare, to
ensure immune reconstitution and minimise
confounding of urinary immune cell profiles. 
 
ExclusionCriteria 
Details  1. Current/ recent infection in the last two weeks before enrolment.
2. Active Malignancy, blood dyscrasias, or current use of chemotherapeutic medications.
3. Patients with co-existing autoimmune diseases and mixed connective tissue diseases.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Characterise the inflammatory cell lymphocyte subset
distribution in the urine by flow cytometry.  		 36 months 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the Extended Panel Urinary Lymphocyte Subsets (EPULS) from the time of recruitment (with high disease activity) and at each follow-up interval (0 months, 3 months, 6 months, and 12 months).
Change in the EPULS profile over time with the class of immunosuppressive drug used for the management of LN. 		 36 months 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Prospective observational EPULS study at Kasturba Medical College and Hospital, Manipal, using standardized midstream urine collection processed within 30 minutes and a dual platform workflow to quantify an 11-color, 12-marker lymphocyte panel by flow cytometry at baseline, 3, 6, and 12 months in lupus nephritis to derive urine immune cell signatures that associate with renal histology (class and scores) and predict clinical remission as a noninvasive, serially trackable biomarker for monitoring. Urine processing follows automated microscopy to guide volume and concentration and acquisition on a flow cytometer under SOP based QC. The 36 month interdepartmental Nephrology and Pathology study embeds monthly induction and three monthly maintenance follow up under standard of care, targeting 30 lupus nephritis participants and 15 disease controls to enable consistent EPULS profiling across visits.

 
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