Physicianbrochure01-04-2008.pub

Your Patient and
Participating Clinical Centers
Information for
Beth Israel Deaconess Medical Center, Boston, MA Physicians
Principal Investigator: Dr. Theodore Steinman As the study moves forward, it may be necessary for HALT PKD to call on you from time to time to request your help with a participant who is under Cleveland Clinic Foundation, Cleveland, OH your care. A Study Investigator or Coordinator Principal Investigator: Dr. William Braun Call (Toll-Free): (800) 223-2273, Extension 44680 • Request relevant medical records, including A Clinical Research Study
Principal Investigator: Dr. Arlene Chapman HALT Progression of
• Request certain lab tests (at study expense) Polycystic Kidney Disease
Kansas University Medical Center, Kansas City, KS • Request follow-up between study visits, if Principal Investigator: Dr. Franz Winklhofer Request assistance in managing an adverse Principal Investigator: Dr. Vicente Torres HALT PKD will inform you of any medically signifi- cant abnormal results from laboratory tests and imaging studies if your patient authorizes release Tufts-New England Medical Center, Boston, MA of his/her Protected Health Information (PHI). Principal Investigator: Dr. Ronald Perrone If you have patients who could benefit from
study participation, we invite them to learn
University of Colorado Health Sciences Center, Denver, CO more by contacting the HALT PKD Project
Principal Investigator: Dr. Robert Schrier Manager at (314) 362-1318.
Sponsored by
They may also visit the HALT PKD website
The National Institute of Diabetes &
at www.pkd.wustl.edu/pkdtn.
Digestive & Kidney Diseases (NIDDK)
The National Institutes of Health (NIH)
Principal Investigator: Professor J. Philip Miller • Travel reimbursement up to $250, plus over- U.S. Department of Health and
night stays, will be provided, if necessary. Human Services
• Clinic visits, lab tests, study medications and a home BP monitor will be provided at no charge. Eligibility Criteria
HALT PKD is a 4-6 year, multi-center study, funded by NIH, in which participants wil be eligi-ble for 1 of 2 studies, depending on their level of kidney function as measured by GFR. Inclusion Criteria
1. Diagnosis of ADPKD.
Study Overview
2. Age 15-49 (Study A); Age 18-64 (Study B). 3. GFR >60 mL/min/1.73 m2 (Study A). Participants will take a combination of either Lisinopril 4. BP ≥130/80 or receiving treatment for hypertension. (ACE-I) and Telmisartan (ARB) or Lisinopril and placebo, with doses titrated to maintain blood pressure (BP) Exclusion Criteria
• Purpose: Evaluate efficacy of dual vs. single
within the assigned range. If necessary, a diuretic and 1. Pregnant/intention to become pregnant within 4-6 yrs. blockade of the renin-angiotensin system on additional antihypertensive medications will be added to kidney cyst growth using a combination of ACE maintain the BP goal. Participants will monitor BP at 3. Spot urine albumin-to-creatinine ratio of >0.5 (Study A) inhibitor (ACE-I) and ARB vs. ACE-I alone and home, with a Study Coordinator phoning every 2 weeks or ≥1.0 (Study B) and/or findings suggestive of kidney usual (120-130/70-80 mm Hg) vs. low blood during titration to discuss BP readings. Dose adjust- pressure control (95-110/60-75 mm Hg), The ments will be made according to protocol, based on these 4. Diabetes requiring insulin or oral hypoglycemic BP readings. Subsequent telephone contact will occur agents / fasting serum glucose of >126 mg/dl / ran- • Outcome: Percent change in kidney volume
every 3 months. Follow-up visits at the study site will dom non-fasting glucose of >200 mg/dl. (cyst growth), as measured by MRI at baseline, occur twice in the 1st year, then every 6 months until the 5. Serum potassium >5.5 mEq/L for participants currently study ends. Serum potassium and creatinine wil be meas- on ACE-I or ARB; >5.0 mEq/L for participants not ured up to 4 times during the 8-week titration period and 6. History of angioneurotic edema or other absolute will be measured at each fol ow-up visit. 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 HALT PKD requires additional safety testing (serum 7. Indication (but not hypertension) for β-blocker or creatinine and potassium) for participants who meet ei- calcium channel blocker therapy, unless approved by • Purpose: Evaluate efficacy of multi-level
blockade of the renin-angiotensin system 8. Systemic illness necessitating NSAIDs, immunosup- using a combination of ACE-I and ARB vs. • Hyperkalemia—High normal or potassium level ≥5.6. pressant or immunomodulatory medications. ACE-I alone on slowing loss of kidney func- 9. Systemic illness with renal involvement. tion independent of blood pressure control. 10.Hospitalized for acute illness in past 2 months. The ARB and control will be masked. HALT PKD will notify the primary care physician or nephrolo- • Outcome: Time to 50% reduction of
gist of any medically significant lab results if the participant has granted authorization for the study to release PHI. 13.Unclipped cerebral aneurysm >7mm diameter. 14.Creatine supplements within 3 months of screening HALT PKD may also ask the primary care physician or HALT PKD may ask the primary care physician or nephrologist to obtain a serum creatinine nephrologist to obtain the required safety labs, serum 15.Congenital absence of a kidney (also total nephrec- sample (at study expense), on occasion, and creatinine and potassium (at study expense), and forward the forward it to the central laboratory at Cleveland 16.Known al ergy to sorbitol or sodium polystyrene 17.Exclusions specific to MR imaging (Study A).

Source: http://www.pkd.wustl.edu/pkd-tn/Participants/PhysicianBrochure.pdf