| CTRI Number |
CTRI/2026/01/101527 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How different stages of kidney disease affect bone health and heart problems |
|
Scientific Title of Study
|
Study on Impact of Chronic Kidney Disease stage on Chronic kidney disease Mineral Bone Disorders and Cardiovascular Outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chava Siri Vennela |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal. |
| Address |
Department of General Medicine, Kasturba Medical College, Mahe, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8897323939 |
| Fax |
|
| Email |
sirivennela.chava11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vasudeva Acharya |
| Designation |
Professor, Unit Head,Department of General Medicine, Kasturba Medical College, Mahe, Manipal. |
| Affiliation |
Kasturba Medical College, Manipal. |
| Address |
Department of General Medicine, Kasturba Medical College, Mahe, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8197597008 |
| Fax |
|
| Email |
vasudeva@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Chava Siri Vennela |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal. |
| Address |
Department of General Medicine, Kasturba Medical College, Mahe, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8897323939 |
| Fax |
|
| Email |
sirivennela.chava11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine, Kasturba Hospital, Manipal. |
|
|
Primary Sponsor
|
| Name |
Department of General Medicine Kasturba Hospital Manipal |
| Address |
Department of General Medicine Kasturba medical college MAHE Manipal. |
| 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 |
| Dr Chava Siri Vennela |
Kasturba Hospital |
Department of General Medicine, Kasturba Hospital, Manipal
Department of Nephrology, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
8897323939
sirivennela.chava11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee Student Research |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged more than 18 years of age with a confirmed diagnosis of CKD. Patients with documented CKD grading based on estimated glomerular filtration rate and albuminuria |
|
| ExclusionCriteria |
| Details |
History of primary bone disorders not related to CKD. Prior parathyroid surgery or other interventions that might effect mineral metabolism. Patients with acute renal failure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the impact of CKD stage( based on estimated glomerular filtration rate and albuminuria level) on bone health and cardiac function |
To study the impact of CKD stage( based on estimated glomerular filtration rate and albuminuria level) on bone health and cardiac function at which outcome will be assessed at baseline, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="157"
Sample Size from India="157"
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)
|
28/01/2026 |
| 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="1"
Months="5"
Days="29" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is a cross sectional observational analysis evaluating how different stages of chronic kidney disease and albuminuria influence the development of CKD MBD and cardiovascular outcomes Patients are grouped according to CKD stage and albuminuria with data collected on clinical parameters renal function biochemical markers of CKD MBD and cardiovascular assessment using ecg and echocardiography |