| CTRI Number |
CTRI/2024/03/064921 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Hydroxychloroquine in diabetic kidney disease |
|
Scientific Title of Study
|
Effect of hydroxychloroquine on progression of diabetic kidney disease in type 2 diabetes mellitus patients: An open labelled randomized controlled trial (pilot 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 |
Dr. Deepak Thiriveedi |
| Designation |
MBBS, MD |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Room number 1, Department of Endocrinology, KLE’s Dr. Prabhakar Kore Hospital and Medical Research Center, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9030000222 |
| Fax |
|
| Email |
deepakthiriveedi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manjunath Goroshi |
| Designation |
MBBS, MD, DM (Endocrinology) |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Room number 1, Department of Endocrinology, KLE’s Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9930270424 |
| Fax |
|
| Email |
manjunath.r.goroshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Deepak Thiriveedi |
| Designation |
MBBS, MD |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Room number 1, Department of Endocrinology, KLE’s Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9030000222 |
| Fax |
|
| Email |
deepakthiriveedi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Instituition (KLE Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka-590010) |
|
|
Primary Sponsor
|
| Name |
KLE Jawaharlal Nehru Medical College |
| Address |
KLE Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka-590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepak Thiriveedi |
KLE Jawaharlal Nehru Medical College |
Room number 1, Department of Endocrinology, KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi, Karnataka, Pin code 590010
Belgaum
KARNATAKA |
9030000222
deepakthiriveedi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard medical therapy |
Comparator group will be treated with appropriate standard medical therapy for a period of 6 months. |
| Intervention |
Standard medical therapy along with Tab Hydroxychloroquine 400 mg once daily for 6 months |
Participants in the study will be divided into two groups. Intervention group will receive appropriate standard medical therapy along with tablet hydroxychloroquine 400 mg once daily for a period of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
all patients more than 18 years of age with diagnose type 2 diabetes mellitus and eGFR 45-90 ml/minute/1.73 sqm and macroalbuminuria |
|
| ExclusionCriteria |
| Details |
renal artery stenosis, end stage renal disease, critical illness, retinal maculopathy, known hypersensistivity to drug, prolonged QT interval, pregnants and lactating females |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in urine albumin creatinine ratio, Change in duration for doubling of serum creatinine, Effect on eGFR
|
Primary outcomes will be assessed at 3 months and 6 months from baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in IL-6 from baseline, change in hsCRP from baseline, change in dose of anti-diabetic drugs, change in dose of anti-hypertensives. |
Secondary outcomes will be assessed at 3 months & 6 months from baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Following informed consent, patients will be randomized into two groups. One group will be started on HCQ once daily with dose adjustments as necessary to a maximum dose of 400mg once daily along with standard therapy. Other group will only receive standard therapy. All patients will be assessed at hospital initially and 3 months and 6 months from initial assessment. Each visit includes interview, physical examination and laboratory investigations. Dosage of drugs for the treatment of diabetes and hypertension will be adjusted to maintain good glycaemic and blood pressure control. ACE inhibitors or ARB’s can be added in both groups as necessary. The following investigations will be carried out initially and at 3 months and 6 months- ECG, HbA1C, fasting and post prandial blood sugars, fundoscopy, serum creatinine level, liver function tests and urinary albumin creatinine ratio. IL-6 and hsCRP will be done initially and at 6 months. Estimated Glomerular filtration rate (eGFR) can be measured using Modification of Diet in Renal Disease (MDRD) Study formula: eGFR= 186 x (Creatinine in mg/ dL)- 1.154 x (Age) - 0.203 x (0.742 if female) Any adverse events during the course of study will be noted and treated accordingly. |