Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)
Conditions
Interventions
Intervention1: Pentosan polysulfate sodium: 90mg hard gelatin oral capsule three times daily for 6 months
Intervention2: Pentosan polysulfate sodium: 90mg hard gelatin oral capsule two times daily for
Sponsors
Dr Hardik Shah
Swati Spentose Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older. Patients with diagnosis of diabetic nephropathy as defined by any degree of proteinuria including micro albuminuria (i.e. Urinary albumin excretion 30-300 mg per 24 hours and above) and eGFR more than 30 ml per min per 1.73m2 and diagnosis of diabetic nephropathy which is confirmed on renal biopsy. (If patient has previously done renal biopsy, the same would be accepted without need of the new renal biopsy for the study) . If, patient refuses Kidney biopsy but has previously established diabetic retinopathy and if the clinical features of renal disease are indicative of diabetic Nephropathy, then patient may be considered as per discretion of the principal investigator’s decision. Patients should be on standard treatment care. For any other anti-hypertensive, lipid-lowering and anti- hyperglycaemic therapies dose should be stable for approximately 4 weeks prior to randomization. Female patients who are of childbearing age, should be compliant with contraceptive regimen during the entire study. Male Patients must be surgically sterile, abstinent, or patient or partner compliant with a contraceptive regimen from screening until 4 weeks after the last dose of study medication. Patients who are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
Exclusion criteria
Exclusion criteria: Known case of non-diabetic renal disease. (Biopsy proven). Systemic anti-vascular endothelial growth factor (VEGF) or pro-VEGF treatment within 3 months prior to randomization. Patients with peptic ulcers, chronic liver disease, known bleeding disorders. Patients with diseases such as aneurysms, thrombocytopenia, haemophilia, gastrointestinal ulcerations, polyps, haemorrhoids, or diverticula. Patients who are on more than one anticoagulants, heparin, t-PA, streptokinase, Patients who are on anti-platelets except aspirin 75 mg per day and clopidogrel 75 mg per day. Patients with history of heparin induced thrombocytopenia. Patients with Macular degeneration, including age-related macular degeneration and polypoidal choroidal vasculopathy. Patients having signs or symptoms of underlying coagulopathy or conditions with increased risk of bleeding. They have a known hypersensitivity to pentosan or have a history of serious adverse event related to any components of investigational product. Sexually active Patients, who are not willing to use contraceptive methods (e.g. hormonal contraceptives, intrauterine devices, barrier methods) and pregnant or lactating women Patients with HIV, Hepatitis B or Hepatitis C infection. Patients with history of hepatic insufficiency, bleeding diathesis, intracerebral haemorrhage Patients with psychiatric disorder or any significant abnormality in pulmonary or central nervous system Patients who participated in any other clinical or post-marketing study (not only for study drugs but also for medical devices) 30 days before signing the informed consent. Any condition which the study investigator judges to preclude safe participation in the study or to confound the evaluation of the study outcome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in urinary albumin to creatinine ratio (UACR) Change in estimated glomerular filtration rate (eGFR) Change in S. CreatinineTimepoint: 0-24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Fibrin & fibrinogen Changes in 24h urinary protein quantity Changes in levels of tumour necrosis factor alpha (TNF-a) and monocyte chemoattractant protein – 1 (MCP-1) Changes in urinary protein or creatinine (UPCR) of morning urine Percentage of participant with at least 2 steps improvement in study eye on ETDRS DRSS ETDRS - Early Treatment Diabetic Retinopathy Study DRSS - Diabetic Retinopathy Severity ScaleTimepoint: 0-24 weeks | — |
Countries
India
Contacts
Public ContactBhupendra Mhatre
Shree Ashirwad Hospital
Outcome results
None listed