HALT Progression of Polycystic Kidney Disease (HALT PKD)
http://www.clinicaltrials.gov/ct/gui/show/NCT00283686?order=5
Drugs Telmisartan  Lisinopril
The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 30-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first two years. Participants enrolled in Study A will be followed for a total of four years, while those enrolled in Study B will be followed for four-to-six years, with the average length of follow-up being five years. The two concurrent randomized clinical trials differ by eligibility criteria, interventions and outcomes to be studied.

Inclusion Criteria:
Diagnosis of ADPKD.
Age 15-49 (Study A); Age 18-64 (Study B).
GFR >60 mL/min/1.73 m2 (Study A); GFR 30-60 mL/min/1.73 m2 (Study B).
BP ≥130/80 or receiving treatment for hypertension.
Informed Consent.

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 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.
Absolute indication (but not hypertension) for β-blocker or calcium channel blocker therapy.
Systemic illness necessitating 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 MR imaging (Study A).

Colorado
      University of Colorado Health Sciences Center, Denver,  Colorado,  80262,  United States; Recruiting
Brittney George  877-765-9297    halt.pkd@uchsc.edu 
Lyn Tison, RN, NP-C  877-765-9297 
Robert Schrier, M.D.,  Principal Investigator
Cass Kelleher, M.D.,  Sub-Investigator

Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States; Recruiting
Diane Watkins  404-686-8280    dpwatki@emory.edu 
Arlene Chapman, M.D.,  Principal Investigator
Frederic Rahbari-Oskoui, M.D.,  Sub-Investigator

Kansas
      University of Kansas Medical Center, Kansas City,  Kansas,  66160,  United States; Recruiting
Jody Mahan, RN, CNN  913-588-7609    jmahan@kumc.edu 
Beth Stafford, RN  913-588-7609    bstafford@kumc.edu 
Franz Winklhofer, M.D.,  Principal Investigator
Jared Grantham, M.D.,  Sub-Investigator

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
Betty Jennings, R.N.  866-650-1815    ejenning@bidmc.harvard.edu 
Theodore Steinman, M.D.,  Principal Investigator

      Tufts University-New England Medical Center, Boston,  Massachusetts,  02111,  United States; Recruiting
Peachy Simon, BSN, RN, CNN  866-846-2735    psimon@tufts-nemc.org 
Ronald Perrone, M.D.,  Principal Investigator
Dana Miskulin, M.D.,  Sub-Investigator

Minnesota
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States; Recruiting
Cynthia Regnier, R.N.  888-630-2616    regnier.cynthia@mayo.edu 
Kristin Cornwell, R.N.  888-630-2616    cornwell.kristin@mayo.edu 
Vicente Torres, M.D.,  Principal Investigator

Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Recruiting
Rita Spirko, R.N.  800-223-2273  Ext. 44680    spirkor@ccf.org 
William Braun, M.D.,  Principal Investigator

Study chairs or principal investigators

Robert Schrier, M.D.,  Study Chair,  University of Colorado   
Arlene Chapman, M.D.,  Principal Investigator,  Emory University   
J. Philip Miller, A.B.,  Principal Investigator,  Washington University School of Medicine   
Ronald Perrone, M.D.,  Principal Investigator,  Tufts University-New England Medical Center   
Vicente Torres, M.D.,  Principal Investigator,  Mayo Clinic   
Catherine Meyers, M.D.,  Study Director,  National Institute of Diabetes & Digestive & Kidney Diseases