HALT Progression of Polycystic Kidney Disease Study B

Exclusion Criteria

• •Pregnant/intention to become pregnant in 4-6 yrs.
• •Documented renal vascular disease.
• •Spot urine albumin-to-creatinine ratio of \>0.5 (Study A) or ≥1.0 (Study B) and/or findings suggestive of kidney disease other than ADPKD.
• •Diabetes requiring insulin or oral hypoglycemic agents / fasting serum glucose of \>126 mg/dl / random non-fasting glucose of \>200 mg/dl.
• •Serum potassium \>5.5 milliequivalent (mEq) /L for participants currently on ACE-I or ARB; \>5.0 mEq/L for participants not currently on ACE-I or ARB.
• •History of angioneurotic edema or other absolute contraindication for ACE-I or ARB. Intolerable cough associated with ACE-I is defined as a cough developing within six months of initiation of ACE-I in the absence of other causes and resolving upon discontinuation of the ACE-I.
• •Indication (other than hypertension) for β-blocker or calcium channel blocker therapy (e.g. angina, past myocardial infarction, arrhythmia), unless approved by the site principal investigator. (PI may choose to accept an individual who is on only a small dose of one of these agents and would otherwise be eligible.)
• •Systemic illness necessitating nonsteroidal antiinflammatory drugs (NSAIDs), immunosuppressant or immunomodulatory medications.
• •Systemic illness with renal involvement.
• •Hospitalized for acute illness in past 2 months.
• •Life expectancy \<2 years.
• •History of non-compliance.
• •Unclipped cerebral aneurysm \>7mm diameter.
• •Creatine supplements within 3 months of screening visit.
• •Congenital absence of a kidney (also total nephrectomy for Study B).
• •Known allergy to sorbitol or sodium polystyrene sulfonate.
• •Exclusions specific to magnetic resonance (MR) imaging (Study A).