Kidney disorder


Kidney Disease

Endpoint parameters

Somajen K 130 Supraselective
(Intra- arterial: renal route)

Somajen K 130 Proprietary biologic / Bone Marrow derived mononuclear cells (autologous trial)

1Y: 30D, 3M, 6M, 12M, Baseline imaging & diagnostic tests: renal ultrasound/CT scan of kidneys and urinary tract (size & malformations), MAG3/DMSA, DSA & CTA, serum Creatinine, urinalysis (protein, RBC), GFR (Glomerular Filtration Rate), urine Albumin-to-Creatinine ratio (ACR), urine dipstick screening for hematuria, blood pressure, urea, potassium, calcium, phosphorus (phosphate), parathyroid hormone (PTH), vitamin D metabolism, edema, hyperphosphatemia; fibroblast growth factor- 23 rates, hypocalcemia, hydroxylase, calciphylaxis, metabolic acidosis, hemoglobin, iron deficiency anemia, tests for recognized genetic mutations; PKD1, PKD2, PKHD1

Nephrogenesis; measurement and comparison over follow-up intervals; of GFR (Glomerular Filtration Rate) through serum Creatinine level, urine Albumin-to- Creatinine ratio (ACR), post controlled intake of any angiotensin converting enzyme inhibitors (ACEIs) & angiotensin II receptor antagonists (ARBs) or phosphate binders; phosphodiesterase-5 inhibitors

Inclusion criteria: Chronic Kidney Disease; Diabetic nephropathy, glomerulonephritis; M/F (Ag18-70); Stages 1,2 & 3A, glomerular filtration rate (GFR) <60 ml/min/1.73 m2 for 3 months and GFR >45 mL/min (Normal GFR is 90-120 mLs/min), Albumin-to-Creatinine ratio (ACR)>30 mg/mmol (albuminuria), at least three months post discontinuation of smoking, alcohol, non-steroidal anti-inflammatory drugs (NSAIDs). Polycystic kidney disease (PKD); congenital history, vasculitis, obstructive nephropathy, high blood glucose and high blood pressure, GFR less than 30 ml/min; or decreasing by more than 3 ml/min/year, dipstick screen for hematuria indicative of a glomerular disorder or a secondary disease amenable to specific treatment, will disqualify subjects, recognized genetic mutations may disqualify patients

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