| CTRI Number |
CTRI/2025/12/098280 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on drug-drug interactions in patients with chronic kidney disease |
|
Scientific Title of Study
|
A Study on Potential Drug-Drug Interactions among Patients with Chronic Kidney Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Leona Sweedal Cutinha |
| Designation |
Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7899342216 |
| Fax |
|
| Email |
cutinhaleona@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandakumar UP |
| Designation |
Assistant Professor Grade II |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice,
NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9633023062 |
| Fax |
|
| Email |
nandakumar@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandakumar UP |
| Designation |
Assistant Professor Grade II |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice,
NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9633023062 |
| Fax |
|
| Email |
nandakumar@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| NITTE(Deemed to be University)Deralakatte, Mangalore,575018 |
|
|
Primary Sponsor
|
| Name |
NITTE (Deemed to be University),NGSM Institute of Pharmaceutical Sciences |
| Address |
Deralakatte, Mangaluru 575018 |
| Type of Sponsor |
Other [( Educational Institution )] |
|
|
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 Pradeep Shenoy M |
Justice KS Hegde Charitable Hospital |
Department of Nephrology,Third Floor, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
9844546066
mpradeepshenoy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC) |
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 |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 18 years, diagnosed with CKD and have received treatment.
Patient prescribed with more than one drug. |
|
| ExclusionCriteria |
| Details |
Patients with incomplete medical records.
Critically ill patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will help to identify and assess the prevalence and severity of drug-drug interactions among chronic kidney disease patients. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Study will evaluate the association between the number of drugs prescribed and the risk of drug-drug interactions |
One year |
|
|
Target Sample Size
|
Total Sample Size="217"
Sample Size from India="217"
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)
|
15/12/2025 |
| 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="6"
Days="0" |
|
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
|
INTRODUCTION: Chronic Kidney Disease (CKD) is kidney damage or reduced function for over three months, affecting 700–850 million people worldwide. Comorbidities like hypertension, diabetes, heart disease, and dyslipidemia cause polypharmacy, raising the risk of pDDIs. These can lower efficacy, prolong hospitalization, increase costs, and cause mortality. Identifying factors aids safer prescribing and better outcomes.
OBJECTIVES OF THE STUDY: To assess the potential drug-drug interactions among patients with chronic kidney disease and to study its severity.
METHODOLOGY: A retrospective observational study will be conducted for a period of six months, from September 2025 to February 2026. The case sheets of inpatients who have undergone treatment for chronic kidney disease in the department of nephrology, from January 2023 to December 2024 will be reviewed from the Medical Records Department. The details pertaining to socio-demographic and clinical parameters as well as treatment related information will be collected in a well-designed data collection form. The potential drug-drug interactions will be identified using UpToDate software.
STATISTICAL ANALYSIS: Statistical analysis will be done using SPSS 29.0. Qualitative data will be presented as frequency and percentage. Quantitative data will be presented as mean ± standard deviation. Factors associated with pDDIs will be analyzed using Chi-square/Fisher’s exact test. A p value <0.05 will be considered statistically significant.
OUTCOME MEASURES: The study is expected to enable early identification and assessment of potential drug-drug interactions in CKD patients, allowing clinicians to implement necessary interventions to optimize therapy. As a result, it could help minimize adverse effects, reduce economic burden, and enhance both therapeutic effectiveness and the overall quality of prescribing. |