HALT Progression of Polycystic Kidney Disease Study A

Summary

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 25-60 mL/min/1.73 m2 (Study B; NCT01885559). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study A will be followed for at least 5 years, while those enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. The two concurrent randomized clinical trials differ by eligibility criteria, interventions and outcomes to be studied.

Conditions

• Kidney, Polycystic

Interventions

DRUG

Lisinopril

Lisinopril titrated to 5mg, 10mg, 20mg, 40mg

DRUG

Telmisartan

Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants

DRUG

Placebo

Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants

OTHER

Standard Blood Pressure Control

Achieve standard blood pressure control of 120-130/70-80 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator

OTHER

Low Blood Pressure Control

Achieve low blood pressure control of 95-110/60-75 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator

Sponsors & Collaborators

• Boehringer Ingelheim

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Polycystic Kidney Disease Foundation

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• Robert Schrier, M.D. · University of Colorado, Denver

• Arlene Chapman, M.D. · Emory University

• Ronald Perrone, M.D. · Tufts University-New England Medical Center

• Vicente Torres, M.D. · Mayo Clinic

• Marva Moxey-Mims, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

• Charity G Moore, MS,PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

15 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2014-06-30

Completion

2014-06-30

FDA Drug

Yes

Countries

• United States

Study Locations