Your Patient and Participating Clinical Centers Information for
Beth Israel Deaconess Medical Center, Boston, MA
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)
• 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).
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