| CTRI Number |
CTRI/2025/12/099920 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Kidney Treatment Options in Patients with Early Kidney Disease |
|
Scientific Title of Study
|
Awareness of Renal Replacement Therapy Options Among Pre-Dialysis CKD Patients: A Cross-Sectional 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 |
Chhaya Sharma |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
LH-11
6th floor
Department of Renal Replacement Therapy and Dialysis Technology
Manipal College of Health Professions
Madhav Nagar
Eshwar Nagar
Manipal
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8352047503 |
| Fax |
|
| Email |
chhaya.mchmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. Bharathi |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions MAHE Manipal |
| Address |
5th Floor 504 Department of Renal Replacement Therapy & Dialysis Technology
Udupi
KARNATAKA
576104
India |
| Phone |
900816894 |
| Fax |
|
| Email |
bharathi.parkala@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivas Vinayak Shenoy |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Kasturba Hospital |
| Address |
Department of Nephrology
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844374705 |
| Fax |
|
| Email |
shenoy.srinivas@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chhaya Sharma |
| Address |
LH-11
6th floor
Manipal College of Health Professions
Madhav Nagar |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Chhaya Sharma |
Kasturba Hospital Manipal |
Department of Nephrology
1st floor OPD
Manipal Karnataka 576104
Udupi
KARNATAKA |
8352047503
chhaya.mchmpl2024@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 Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are above 18 years old and are diagnosed with CKD stages 4–5 (as per KDIGO staging). |
|
| ExclusionCriteria |
| Details |
Patients who have received any form of RRT in the past due to AKI or prior kidney transplant.
Patients with cognitive impairments or conditions that limit their ability to participate.
Patients who cannot read and write.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Awareness of Renal Replacement Therapy (RRT) Options measured by yes/no. |
At baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Awareness of diagnosis and overall treatment options measured by yes/no.
2 Whether the patient has received counselling on RRT measured by yes/no.
3 Perceived Barriers to RRT Knowledge measured by Likert scale responses to barriers such as lack of time, financial status, education level etc. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="303"
Sample Size from India="303"
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)
|
05/01/2026 |
| 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="0"
Months="7"
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
|
This cross-sectional study aims to assess the level of awareness of renal replacement therapy options among pre-dialysis CKD patients. It also aims to identify factors and barriers that influence patients’ knowledge and understanding of available treatment modalities. Data will be collected using a structured questionnaire from eligible CKD patients. The results of this study are expected to identify gaps in patient awareness and highlight the need for structured education and counselling. |