| CTRI Number |
CTRI/2024/08/072194 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of possible interactions between different drugs in older adult patients with chronic kidney disease |
|
Scientific Title of Study
|
Analysis Of Potential Drug Drug Interactions and Their Association with Patient Demographic and clinical Characteristics in elderly Chronic Kidney Disease patients A Prospective 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 |
Akshay Balakrishna |
| Designation |
Post graduate |
| Affiliation |
KMC Manipal |
| Address |
Department of Pharmacology, Kasturba Medical College and Hospital, Manipal , Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8747828873 |
| Fax |
|
| Email |
akshay.bala1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Bharti Chogtu Magazine |
| Designation |
Additional Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Pharmacology, Kasturba Medical College and Hospital, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9901728668 |
| Fax |
|
| Email |
bharti.magazine@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Akshay Balakrishna |
| Designation |
Post graduate |
| Affiliation |
KMC Manipal |
| Address |
Department of Pharmacology, Kasturba Medical College and Hospital, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8747828873 |
| Fax |
|
| Email |
akshay.bala1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal, Udupi, Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Dr.Akshay Balakrishna |
| Address |
Department of Pharmacology, Kasturba medical college and Hospital, Madhav Nagar, Saralabettu, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [Principle Investigator] |
|
|
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 Akshay Balakrishna |
Kasturba Medical College, Manipal |
Kasturba Medical College and Hospital, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8747828873
akshay.bala1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital, Institutional Ethics Comittee-2 (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
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients above the age of 65 years
Patients of either genders
Patients diagnosed of CKD
Patients on five or more drugs |
|
| ExclusionCriteria |
| Details |
Patients less than the age of 65 years
Patients with incomplete history
Acute Renal Injury
Patients on less than 5 drugs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Grading of potential drug-drug interactions
|
At baseline - one point collection of data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predictors of the drug drug interactions |
At baseline - One point data collection |
|
|
Target Sample Size
|
Total Sample Size="436"
Sample Size from India="436"
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)
|
08/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/10/2024 |
| 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)
Modification(s)
|
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
|
Patients of Chronic Kidney Disease(CKD) are on multiple drugs. The elderly patients suffering from CKD due to their unique metabolism tend to be at a higher risk for drug-drug interactions Early identification and detection of potential drug interactions can prevent and benefit in management of elderly patients with CKD. This modality can improve the quality of life for these patients, which in turn can lead to reduced hospitalizations and lessen the strain on the healthcare system.This study deals with identifying potential drug drug interactions in patients with chronic kidney disease who are on more than 5 drugs. The drug interactions will be graded as per the LEXICOMP and the various predictors of the drug interactions will be identified and reported. |