CTRI/2014/12/005341OtherPhase 2
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.
Ipca Laboratories Ltd Mumbai22 sites in 1 country308 target enrollmentStarted: February 2, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Other
- Sponsor
- Enrollment
- 308
- Locations
- 22
- Primary Endpoint
- 1.To assess the change from baseline in estimated glomerular filtration rate (eGFR) with hydroxychloroquine as an add on therapy as compared with placebo.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Double Blind Double Dummy
Eligibility Criteria
- Ages
- 30.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1.To assess the change from baseline in estimated glomerular filtration rate (eGFR) with hydroxychloroquine as an add on therapy as compared with placebo.
Time Frame: At the end of 24 weeks and 52 weeks.
Secondary Outcomes
- 1. Proportion of patients reporting fall in eGFR(2.Change in eGFR 4 weeks after last adminstration of study drug)
Investigators
Study Sites (22)
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