| CTRI Number |
CTRI/2022/10/046910 [Registered on: 31/10/2022] Trial Registered Prospectively |
| Last Modified On: |
11/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of the Middle molecule clearance in patients of chronic kidney disease (CKD) undergoing Renal Replacement Therapy by different modalities |
|
Scientific Title of Study
|
Comparison of the Fibroblast Growth Factor (FGF -23) and Beta 2 microglobulin (β2M) levels in patients of chronic kidney disease (CKD) undergoing Renal Replacement Therapy (Haemodialysis vs Hemodiafiltration) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parikshit Chauhan |
| Designation |
Nephrologist |
| Affiliation |
AFMC |
| Address |
Department of Internal Medicine
Pune
MAHARASHTRA
411040
India |
| Phone |
9872629226 |
| Fax |
|
| Email |
parikshitchauhan78@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Parikshit Chauhan |
| Designation |
Nephrologist |
| Affiliation |
AFMC |
| Address |
Department of Internal Medicine
Pune
MAHARASHTRA
411040
India |
| Phone |
9872629226 |
| Fax |
|
| Email |
parikshitchauhan78@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Parikshit Chauhan |
| Designation |
Nephrologist |
| Affiliation |
AFMC |
| Address |
Department of Internal Medicine
Pune
MAHARASHTRA
411040
India |
| Phone |
9872629226 |
| Fax |
|
| Email |
parikshitchauhan78@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Director General Armed Forces Medical Services
Office of DGAFMS L Block
Ministry of Defence
New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
DGAFMS |
| Address |
Office of DGAFMS
Ministry of Defence
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Parikshit Singh Chauhan |
Armed Forces Medical College |
Department of Internal Medicine , AFMC, sholapur Road
Pune
MAHARASHTRA |
9872629226
parikshitchauhan78@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AFMC Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N17-N19||Acute kidney failure and chronic kidney disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Haemodiafiltration |
To check for middle molecule clearance in Haemodiafiltration vs haemodialysis in CKD stage 5 patients. Patients would be provided Renal replacement therapy by each of the above modality twice a week for six weeks and their middle molecule levels would be compared |
| Comparator Agent |
Hemodialysis |
To check for middle molecule clearance in Haemodiafiltration vs haemodialysis in CKD stage 5 patients. Patients would be provided Renal replacement therapy by each of the above modality twice a week for six weeks and their middle molecule would be compared. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Eligible adults of CKD 5D aged at least 18 years of age who have been initiated on any one of the two modalities of dialysis
Individual should have functional AV fistula with blood flow more than 300 ml/min
|
|
| ExclusionCriteria |
| Details |
Patients not having AV Fistula as vascular access in HDF and HD group
2. Patients not giving written informed consent will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Levels of FGF-23 and Beta 2 microglobulin |
At Initiation of dialysis modality(0 week) and six(6) weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/12/2022 |
| 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="3"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic kidney disease is associated with higher rates of cardiovascular morbidities and mortalities as compared to general population. One of the proposed mechanism is poor clearance of fibroblast growth factor -23, beta 2 microglobulin, leptin, myoglobin etc with use of conventional haemodialysis and peritoneal dialysis. With introduction of online haemodiafiltration ( HDF) there have studies mentioning decrease in complications like anemia, mineral bone disease , cardiovascular illnesses and mortality since above mentioned molecules are removed by convection only. Hence to prolong lifespan of CKD patients, the role of middle molecule clearance needs to be explored,
|