| CTRI Number |
CTRI/2024/05/068172 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
Effect of Hydroxychloroquine drug on progression of Diabetes related Kidney disease |
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Scientific Title of Study
|
Effect of Hydroxychloroquine on Diabetic Nephropathy – a Randomized Controlled Trial |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Varun Kumar Bandi |
| Designation |
Associate Professor, Dept Of Nephrology |
| Affiliation |
Dr. Pinnamaneni Siddhartha Institute of Medical Sciences |
| Address |
Dialysis Unit, Second Floor, Super Specilaity Block, Dr. Pinnamaneni Siddhartha Hospital, Chinna Avutapalli
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
7708396309 |
| Fax |
|
| Email |
varun.vims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varun Kumar Bandi |
| Designation |
Associate Professor, Dept Of Nephrology |
| Affiliation |
Dr. Pinnamaneni Siddhartha Institute of Medical Sciences |
| Address |
Dialysis Unit, Second Floor, Super Specilaity Block, Dr. Pinnamaneni Siddhartha Hospital, Chinna Avutapalli
ANDHRA PRADESH
521286
India |
| Phone |
7708396309 |
| Fax |
|
| Email |
varun.vims@gmail.com |
|
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Source of Monetary or Material Support
|
| Dr. Pinnamaneni Siddhartha Institute of Medical Sciences |
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Primary Sponsor
|
| Name |
Dr Varun Kumar Bandi |
| Address |
Dialysis Unit, Second Floor, Super Specilaity Block, Dr. Pinnamaneni Siddhartha Hospital, Chinna Avutapalli |
| Type of Sponsor |
Other [Self sponsor] |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Varun Kumar Bandi |
Dr Pinnamaneni Siddhartha Institute of Medical Sciences and RF |
Chinna Avutapalli
Krishna
ANDHRA PRADESH |
7708396309
varun.vims@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E10||Type 1 diabetes mellitus, (2) ICD-10 Condition: E102||Type 1 diabetes mellitus with kidney complications, (3) ICD-10 Condition: E11||Type 2 diabetes mellitus, (4) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Hydroxychloroquine |
Hydroxychloroquine tablet is given at a dose of 200mg twice a day after food for 6 months. |
| Comparator Agent |
Placebo |
Multivitamin tablets of similar size, shape, and color (Tab. Beplex forte) will be given as a placebo twice a day for 6 months |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Presence of Diabetic Nephropathy |
|
| ExclusionCriteria |
| Details |
1. Pregnant Women
2. People not consenting for study
3. Participation in any other clinical trial
4. History of intolerance to study drug
5. Patients with history of cardiac arrhythmias or prolonged QT interval
6. Patients with severe retinopathy
7. Patients requiring in-patient admission at time of enrolment
8. Any other condition which in the opinion of the investigator, would put the safety of the participant at risk, impede compliance or hinder completion of the study
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Pharmacy-controlled Randomization |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Change in proteinuria
2. Change in estimated glomerular filtration rate |
12 weeks, 24 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Effect of hydroxychloroquine on glycemic control
2. Effect of hydroxychloroquine on lipid profile |
6 months |
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Target Sample Size
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Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 4 |
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Date of First Enrollment (India)
|
24/06/2024 |
| 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 |
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Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Early identification and management of diabetes-related complications could help in preventing progression to End stage renal disease. Better management strategies lead to delaying the development of diabetic complications. All patients with type 2 diabetes presenting to the Department of General Medicine or Nephrology will be evaluated for inclusion in the study. The subjects will be followed up for a period of 6 months. It is a Single-center, randomized, double blind, placebo-controlled trial, with a total of 60 participants (30 experimental arm, 30 placebo arm). The study will have a 4 week run-in period during which telmisartan dose will be maximised, followed by drug initiation with a 6 month follow up. Participants will receive placebo or hydroxychloroquine twice a day. Hydroxychloroquine will be given at a dose of 200mg twice a day if subjects weight is more than 40kg, or 100mg od if less than 40kg. At baseline, demographic characteristics such as Age, Gender, duration of Diabetes Mellitus, history of Hypertension, Cardiac disease, and CKD will be obtained. The subject’s blood pressure, Hemoglobin, Random blood sugar, Creatinine, urine albumin to creatinine ratio (UACR) will be evaluated at randomisation. The following investigations will be done at the end of run-in period, and at end of 6 months: Hemoglobin, Fasting Blood Sugar, Serum Creatinine, highly sensitive C-reactive peptide, fasting serum Insulin, UACR, HbA1c and lipid profile.
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