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Clinical trial

Clinical Study Evaluating the Nephroprotective Effect of Nicorandil in Patients With Type 2 Diabetes Mellitus

ID
Name
Nicorandil Nephroprotective
Description
This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .
Trial arms
Trial start
2023-02-28
Estimated PCD
2025-02-01
Trial end
2025-02-01
Status
Recruiting
Phase
Early phase I
Treatment
Nicorandil 10 MG Oral Tablet
Nicorandil 10 MG oral tablet twice daily
Arms:
Nicorandil group
Size
46
Primary endpoint
prevention of progression of kidney disease as measured by KDIGO.
12 weeks
Eligibility criteria
Inclusion Criteria: * Patients newly diagnosed with T2DM with diet control and good glycemic index ( Hb A1C\< 7 ) * Age range between 18 and 60 years old. * Both sexes. * Stage 1and Stage 2 CKD according to KDIGO . * Controlled HTN . Exclusion Criteria: * Pregnant and lactating females. * Patients with hypersensitivity to nicorandil. * Other Causes of CKD or Nephropathy eg : Uncontrolled HTN , Renal Malignancy , collagen disease as Amyloidosis and some autoimmune disease as ( SLE and Rh.fever ) . * Uncontrolled HTN and its antihypertensive medications ( ACEI , ARB ) and other antihypertensive medications . * Patients receiving nephrotoxic drugs as aminoglycosides, non-steroidal anti inflammatory drugs and contrast media.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}
Updated at
2024-05-28

1 organization

1 product

1 indication

Organization
Tanta University
Product
Nicorandil
Indication
Type 2 Diabetes Mellitus