CTRI/2014/12/005341 [Registered on: 31/12/2014] Trial Registered Prospectively
Last Modified On:
15/05/2017
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
Evaluation of Efficacy and Safety of Hydroxychloroquine in type-II diabetes patients with chronic kidney disease.
Scientific Title of Study
A Dose Ranging Study to Evaluate the Role of Hydroxychloroquine in Preserving the Kidney Function by Slowing Down the Progression of Kidney Disease Due to Type-II Diabetes.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Ipca/LHCQ/PII-12, Version No. 2, dated 28/02/2014
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Department of Nehprology,All India Institute of Medical Sciences, Ansari Nagar, New Delhi – 110 029 North DELHI
9868397402
skagarwalnephro@gmail.com
DrGPrasad
Andhra Medical College and King George Hospital
Department of Nephrology,Andhra Medical College and King George Hospital, Jagadamba Area,KGH,Down Road, Maharanipeta,Visakhapatnum-530002 Visakhapatnam ANDHRA PRADESH
9848238292
drgullipulli123@yahoo.com
Dr Nisith Kumar Mohanty
Apollo Hospital, Bhubaneswar
Consultant, Department of Nephrology,Apollo Hospital,Plot No.251, Old Sainik School Road, Bhubaneswar-750015 Khordha ORISSA
9337103451
mrmkidney@yahoo.co.in
Dr Pratim Sengupta
Belle Vue Clinic,Kolkata
Consultant, Department of Nephrology Belle Vue Clinic,9, Dr. U.N. Brahmachari Street,Kolkata-700017 Kolkata WEST BENGAL
9830099686
pratim.sengupta@gmail.com
DrNandita Choudhury
Down Town Hospital,Dispur, Guwahati
Consultant, Department of Nephrology,Down Town Hospital,GS Road Dispur,Guwahati-781006 Kamrup ASSAM
1. Placebo of Hydroxychloroquine tablet Dose - 100mg
2. Placebo of Hydroxychloroquine tablet Dose - 150mg
3. Placebo of Hydroxychloroquine tablet Dose - 200mg
Fequency -OD, Duration-52weeks and route- PO
Inclusion Criteria
Age From
30.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
General Health
1.Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition.
Conditions under study
2.Patients with moderately decreased eGFR (30-59 mL/min per 1.73 m2) calculated using abbreviated Modification of Diet in Renal Disease [aMDRD] and having type II diabetes (HbA1c value ≥7% and ≤ 10%).
Compliance
3.Patient must understand and be able, willing and likely to fully comply with study procedures and restrictions.
4.Patients ready to undergo a follow-up period of 56weeks.
Informed Consent
5.Patient must have given written, personally signed and dated, informed consent to participate in the study, in accordance with the current applicable regulations, International Conference on Harmonization (ICH), Good Clinical Practice (GCP) Guidelines, before initiating any study related procedures.
ExclusionCriteria
Details
1.Patients with kidney failure i.e. end stage renal disease (ESRD) requiring dialysis or renal transplantation).
2.Patients with proteinuria 3.0 g/24 hour.
3.Patients with diastolic blood pressure (DBP) ≥ 110 mmHg.
4.Patients with type I diabetes.
5.Patients with abnormal ECG and/or history of significant cardiovascular disease
6.Patients with non-diabetic kidney disease.
7.Patients with hyperkalemia (serum potassium 5.5 mEq/L) or requiring treatment with drugs known to increase serum potassium levels.
8.Patients with history of myopathy or neuromyopathy.
9.Patients with unilateral or bilateral renal artery stenosis.
10.Patients with liver dysfunction
11.Patients with disease of blood or hematopoietic organs (hemoglobin 10 g/dL)
12.Patients with G6PD deficiency.
13.Patients with proliferative diabetic retinopathy or those with retinal or visual field changes attributable to 4-aminoquinoline derivatives or to any other etiology.
14.Patients with known history of HIV 1 or HIV 2, Hepatitis B or C Viruses or syphilis infection.
15.Patients with known history of hypersensitivity to study drugs
16.Patients with history of drug dependence, other substance abuse or excessive alcohol intake on habitual basis
17.Patients who have used another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment.
18.Pregnant or lactating women.
19.Women of childbearing potential not practicing contraception.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
1.To assess the change from baseline in estimated glomerular filtration rate (eGFR) with hydroxychloroquine as an add on therapy as compared with placebo.
At the end of 24 weeks and 52 weeks.
Secondary Outcome
Outcome
TimePoints
1. Proportion of patients reporting fall in eGFR
2.Change in eGFR 4 weeks after last adminstration of study drug
4. Incidence of primary non-fatal cardiovascular events
5. Cardiovascular mortality
6.Need for ESA or change in dose of ESA
7. To Compare safety and tolerability
8.Change in Urine albumin to creatinine ratio,HbA1c, BUN, Sr. Creatinine,Uric acid serum potassium, hemoglobin,lipid profile,HsCRP
week 52
Target Sample Size
Total Sample Size="308" Sample Size from India="308" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
The primary purpose of conducting this study is to evaluate the role of hydroxychloroquine in preservig the kidney function by slowing down the progression of knidney diseasedue to type-II diabetes. Considering the multifaceted effects of hydroxychloroquine and corresponding pathophysiological mechanisms involved in diabetic nephropathy, we propose that concurrent use of hydroxychloroquine along with ACE inhibitor or ARB or their combination with other antihypertensive agents may slow down the progression of chronic kidney disease in type-II diabetic patients.