The HALT Progression of Polycystic Kidney Disease

Autosomal dominant polycystic kidney disease (ADPKD) impacts 1 in 400 to 1 in 1000 live births and accounts for about 4.6% of the kidney replacement population in the US. Hypertension is the most common manifestation and an important risk factor for its progression to end stage renal disease (ESRD) and cardiovascular morbidity and mortality.

The HALT Progression of Polycystic Kidney Disease (HALT PKD) studies were two simultaneous multicenter clinical trials designed to test the efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and the decline in renal function in ADPKD. Specifically, the studies assessed the effects of ACE-I/ARB combination therapy as compared to ACE-I monotherapy in hypertensive ADPKD subjects.

The two studies varied on eligibility criteria (particularly kidney function), blood pressure treatment, and primary outcome measure. Study A investigates treatment effects on individuals with early ADPKD and implements a standard (120-130/70-80 mm Hg) vs. low (95-110/60-75 mmHg) blood pressure control target for both treatment arms in a 2x2 design. Study B investigates treatment effects on individuals with moderately advanced ADPKD in the setting of standard blood pressure control (110-130/80 mm Hg). Participants enrolled in study A were followed for at least five years, while those enrolled in study B were followed for five to eight years, with the average length of follow-up being six and a half years.

The complete HALT PKD data package is available for request.