| CTRI Number |
CTRI/2024/01/060994 [Registered on: 01/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to assess response of a drug that treats low red blood cells count in chronic kidney disease patients |
|
Scientific Title of Study
|
A prospective observational study to assess serum magnesium level and its correlation with ESA responsiveness in anemia in CKD patients at a tertiary care hospital in Uttarakhand |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawna Saini |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, RISHIKESH |
| Address |
Room no- 3005, Department of Pharmacology, level-4, Academic block, AIIMS
Virbhadra Road
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7247868911 |
| Fax |
|
| Email |
bhanu.gsvm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Dhamija |
| Designation |
Professor |
| Affiliation |
AIIMS, RISHIKESH |
| Address |
Room no- 3004, Department of Pharmacology, level-4, Academic block, AIIMS
Virbhadra road
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000292 |
| Fax |
|
| Email |
puneet.phar@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Dhamija |
| Designation |
Professor |
| Affiliation |
AIIMS, RISHIKESH |
| Address |
Room no- 3004, Department of Pharmacology, level-4, Academic block, AIIMS
Virbhadra road
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000292 |
| Fax |
|
| Email |
puneet.phar@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Account section for research project, AIIMS, RISHIKESH, Uttaranchal, India
Pincode- 249203 |
|
|
Primary Sponsor
|
| Name |
BHAWNA SAINI |
| Address |
Room no- 3005, Department of Pharmacology, AIIMS, Rishikesh, Uttaranchal, India
Pincode- 2492023 |
| 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 |
| Dr BHAWNA SAINI |
AIIMS |
Department of Nephrology and Department of Pharmacology,
level-4, Academic block, AIIMS, RISHIKESH
Dehradun
UTTARANCHAL |
7247868911
bhanu.gsvm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (3) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (4) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-70 years of either sex
2. Patients that have CKD Stage-3-5
|
|
| ExclusionCriteria |
| Details |
1. Infectious disease
2. Active liver disease
3. Neoplastic disease on cytotoxic chemotherapy
4. Recent cardio-cerebrovascular disease
5. Blood transfusions or surgical procedures within last 4 weeks
6. Active bleeding or pure red cell aplasia
7. Patients receiving phosphate binder containing magnesium or laxatives containing magnesium. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To study the serum magnesium level in CKD stage 3-5 patients |
•To study the serum magnesium level in CKD stage 3-5 patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate serum magnesium level with the severity of anemia |
BASELINE (DAY-1) AND AFTER 1 MONTH |
| To correlate serum magnesium level with the erythropoiesis stimulating agents responsiveness in the anemia in chronic kidney disease patient |
BASELINE (DAY-1) AND AFTER 1 MONTH |
| To identify adverse drug reactions associated with erythropoiesis stimulating agents responsiveness in the anemia in chronic kidney disease patient |
BASELINE (DAY-1) AND AFTER 1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="121"
Sample Size from India="121"
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)
|
08/01/2024 |
| 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="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
|
The purpose of this
study is to assess serum magnesium level in chronic kidney disease (CKD)
patients and establish it’s correlation with Erythropoiesis-stimulating agents (ESA)
responsiveness in anemia in CKD patients. Low level of Serum Magnesium can
increase requirement of higher doses of ESAs drugs for treatment of anemia in
CKD. Establishment of association of serum Magnesium and ESAs
hyporesponsiveness can help to correct serum Magnesium levels at early stages of
CKD to reduce need of ESAs administration. |