| CTRI Number |
CTRI/2024/08/072708 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Discovery of molecular signature to understand Chronic Kidney Disease (CKD) |
|
Scientific Title of Study
|
Genomic analysis of different stages of Chronic Kidney Disease (CKD) in Indian Population |
| 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 Vamsi Veeramachaneni |
| Designation |
Chief Scientific Officer |
| Affiliation |
Strand Life Sciences Pvt Ltd |
| Address |
Department of Clinical Research, Delivery Division, Room No #01, University of Agricultural Sciences, Convention
Centre, Veterinary College Campus, Bellary Road,
Bengaluru, Karnataka, INDIA
Bangalore
KARNATAKA
560024
India |
| Phone |
08023095200 |
| Fax |
|
| Email |
vamsi@strandls.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vamsi Veeramachaneni |
| Designation |
Chief Scientific Officer |
| Affiliation |
Strand Life Sciences Pvt Ltd |
| Address |
Department of Clinical Research, Delivery Division, Room No #01,University of Agricultural Sciences, Convention
Centre, Veterinary College Campus, Bellary Road,
Bengaluru, Karnataka, INDIA
Bangalore
KARNATAKA
560024
India |
| Phone |
08023095200 |
| Fax |
|
| Email |
vamsi@strandls.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vamsi Veeramachaneni |
| Designation |
Chief Scientific Officer |
| Affiliation |
Strand Life Sciences Pvt Ltd |
| Address |
Department of Clinical Research, Delivery Division, Room No #01, University of Agricultural Sciences, Convention
Centre, Veterinary College Campus, Bellary Road,
Bengaluru, Karnataka, INDIA
Bangalore
KARNATAKA
560024
India |
| Phone |
08023095200 |
| Fax |
|
| Email |
vamsi@strandls.com |
|
|
Source of Monetary or Material Support
|
| Strand Life Sciences Pvt Ltd, Room No # 01, University of Agricultural Sciences, Convention
Centre, Veterinary College Campus, Bellary Road,
Bengaluru, Karnataka, INDIA - 560024 |
|
|
Primary Sponsor
|
| Name |
Strand Life Sciences Pvt Ltd |
| Address |
Room No # 01, University of Agricultural Sciences, Convention Centre, Veterinary College Campus, Bellary Road, Bengaluru, Karnataka, INDIA - 560024 |
| Type of Sponsor |
Other [Research Organization] |
|
|
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 Ketan Kshirsagar |
Sangvi Multispeciality Hospital Pvt Ltd |
Room No-#01, Sr No 71/1/2/189,CS No 2387,Shirode Road, Vinayak Nagar Ln. No. 2, near Krushna Chowk, Krishna Nagar, New Sangavi, Pune, Maharashtra 411027
Pune
MAHARASHTRA |
9049002749
drketan.sangvihospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SANGVI MULTISPECIALITY HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (2) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (3) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (4) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of 18 years or above with confirmed diagnosis of CKD with eGFR less than 90 ml/min and
other available clinical parameters (age of onset, method of diagnosis, phenotypic characteristics,
any information on repeated occurrence, associated SOC test results)
Individuals from the general population of any sex and race
Individuals who has the ability to understand and willing to sign the Informed consent form
Willingness to contribute 20-23 ml blood |
|
| ExclusionCriteria |
| Details |
Patients with acute nephrology disorders or disorders pertaining to autoimmune or genetic
conditions like lupus nephritis or polycystic kidney disease
Patients not consenting or unable to give an informed written consent
Patients not meeting the inclusion criteria or judged by the investigator to be unsuitable for
inclusion into the study
Pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Identification of signature biomarkers via a minimally invasive procedure will enable
identification of pivotal genetic factors that contribute to the development and progression of
different stages of CKD. |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
26/08/2024 |
| 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) |
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
|
Study Synopsis Study Number: SLS-CKD-01 Study Title: Genomic analysis of different stages of Chronic Kidney Disease (CKD) in
Indian Population
Study Sponsor: Strand Life Sciences Private Limited Study Type: Exploratory, Observational, Non-interventional, Multi-centric Study Site(s): Multiple Total number of Subjects: 1000 (250 for each cohort) Study Arms: Arm 1: Affected arm subdivided into 4 cohorts: Cohort I: Mild CKD (eGFR 60-89 ml/min) Cohort II: Moderate to Severe CKD (eGFR 30-59 ml/min) Cohort III: Severe CKD (eGFR 15-29 ml/min) Cohort IV: End Stage CKD (eGFR <15 ml/min) Rationale Given the rising prevalence of this disease in India, it would be beneficial to carry out ethnically diverse multi-centric large-scale research. To understand the genotype-phenotype associations with the different stages of CKD, this study intends to sequence patients with different stages of CKD in comparison to healthy persons without symptoms or a susceptibility to the disease.Successful completion of the study will aid in the identification of potential genomic markers for identifying high-risk people who are at risk of getting CKD may be discovered and also identify potential therapeutic targets for the disease. Objective To discover genotype-phenotype correlations in individuals with different stages of diagnosed CKD |