HALT Progression of Polycystic Kidney Disease (HALT PKD)
5 year blood pressure study of PKD
Drugs Telmisartan Lisinopril
Tight blood pressure control is thought to delay dialysis and/or transplant by at least 15 years. The HALT study is testing which blood pressure medications are best for PKD'rs. Some antihypertensive medications increase the blood supply to the kidneys, decrease proteinuria, and lower blood pressure.
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.
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.
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).
A few PKD HALT Sites:
University of Colorado Health Sciences Center, Denver, Colorado, 80262, United States; Recruiting
Brittney George 877-765-9297 firstname.lastname@example.org
Lyn Tison, RN, NP-C 877-765-9297
Robert Schrier, M.D., Principal Investigator
Cass Kelleher, M.D., Sub-Investigator
Emory University School of Medicine, Atlanta, Georgia, 30322, United States; Recruiting
Diane Watkins 404-686-8280 email@example.com
Arlene Chapman, M.D., Principal Investigator
Frederic Rahbari-Oskoui, M.D., Sub-Investigator
University of Kansas Medical Center, Kansas City, Kansas, 66160, United States; Recruiting
Jody Mahan, RN, CNN 913-588-7609 firstname.lastname@example.org
Beth Stafford, RN 913-588-7609 email@example.com
Franz Winklhofer, M.D., Principal Investigator
Jared Grantham, M.D., Sub-Investigator
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Betty Jennings, R.N. (866)650-1815 firstname.lastname@example.org Theodore Steinman, M.D., Principal Investigator Massachusetts
Tufts University-New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
Peachy Simon, BSN, RN, CNN 866-846-2735 email@example.com
Ronald Perrone, M.D., Principal Investigator
Dana Miskulin, M.D., Sub-Investigator