| CTRI Number |
CTRI/2025/07/091694 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the Daily Life of People with Lupus Nephritis Taking Immunosuppressive Treatment |
|
Scientific Title of Study
|
Living with Lupus Nephritis: Evaluating Quality of Life in Patients on Immunosuppressive Therapy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajna Angeline D Souza |
| Designation |
PhD Scholar |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal. |
| Address |
Department of Nephrology, Kasturba Hospital, 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
Scientific Query
|
| Name |
Dr Dharshan Rangaswamy |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal. |
| Address |
Department of Nephrology, Kasturba Hospital, 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
Public Query
|
| Name |
Dr Dharshan Rangaswamy |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal. |
| Address |
Department of Nephrology, Kasturba Hospital, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal.
KARNATAKA
576104
India |
| Phone |
9901970787 |
| Fax |
|
| Email |
dharshan.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital, Manipal, Manipal Academy of Higher Education, Manipal.
Udupi District, Karnataka, India.
Pin code - 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education Manipal |
| Address |
Kasturba Medical College and Kasturba Hospital, Manipal, Manipal Academy of Higher Education, Manipal.
Udupi District, Karnataka State, India.
Pin code - 576104 |
| Type of Sponsor |
Private 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 |
| Prajna Angeline D Souza |
Kasturba Medical College and Kasturba Hospital, Manipal, MAHE, Manipal. |
Room no. 15, Department of Nephrology.
Udupi
KARNATAKA |
7022737001
prajna.kmcmpl2024@learner.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
|
|
|
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 |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed as SLE by SLICC/ACR criteria and biopsy-proven lupus nephritis (Class III/IV/V
combinations).
Has completed induction immunosuppressive regimen for at least 6 months and is on
maintenance therapy for LN.
Able to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with overlap syndromes, post-kidney transplant ESKD on dialysis, and patients not on
immunosuppressive drugs for LN.
Severe psychiatric illness interfering with questionnaire completion.
Recent hospital admission, serious infection, cancer, or an acute illness in the past 4 weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of this study is the Mean overall Quality of Life (QoL) score as measured by the
LupusQoL and EQ-5D-5L instruments in patients with lupus nephritis who are on maintenance
immunosuppression. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Domain-specific QoL scores from LupusQoL.
Comparison of QoL scores between different LN classes (e.g., Class III, IV, V combinations) and disease
remission states.
Impact of steroid burden (cumulative dose and current dose) on QoL scores and proportion of patients
reporting moderate to severe impairment in specific EQ-5D-5L dimensions (mobility, self-care, usual
activities, pain/discomfort, anxiety/depression) and obtaining mean health utility score derived from EQ
5D-5L responses using the Indian value set. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2029 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 - NO
|
|
Brief Summary
|
This is a prospective, cross-sectional observational study designed to assess the quality of life (QoL) in patients with biopsy-proven lupus nephritis (LN) who have completed at least six months of maintenance immunosuppressive therapy. Using validated instruments (LupusQoL and EQ-5D-5L), the study evaluates overall and domain-specific QoL and explores associations with disease class, remission status, steroid burden, treatment type, and clinical markers. The study aims to generate patient-centered insights to inform individualized care and integration of QoL assessment in routine LN management. |