The HALT polycystic kidney disease trials: Design and implementation

Arlene B. Chapman, Vicente E. Torres, Ronald D. Perrone, Theodore I. Steinman, Kyongtae T. Bae, J. Philip Miller, Dana C. Miskulin, Frederic Rahbari Oskoui, Amirali Masoumi, Marie C. Hogan, Franz T. Winklhofer, William Braun, Paul A. Thompson, Catherine M. Meyers, Cass Kelleher, Robert W. Schrier

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Abstract

Background and objectives: Two HALT PKD trials will investigate interventions that potentially slow kidney disease progression in hypertensive autosomal dominant polycystic kidney disease (ADPKD) patients. Studies were designed in early and later stages of ADPKD to assess the impact of intensive blockade of the renin-angiotensin-aldosterone system and level of BP control on progressive renal disease. Design, settings, participants, and measurements: PKD-HALT trials are multicenter, randomized, double-blind, placebocontrolled trials studying 1018 hypertensive ADPKD patients enrolled over 3 yr with 4 to 8 yr of follow-up. In study A, 548 participants, estimated GFR (eGFR) of >60 ml/min per 1.73 m2 were randomized to one of four arms in a 2-by-2 design: combination angiotensin converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB) therapy versus ACEi monotherapy at two levels of BP control. In study B, 470 participants, eGFR of 25 to 60 ml/min per 1.73 m 2 compared ACEi/ARB therapy versus ACEi monotherapy, with BP control of 120 to 130/70 to 80 mmHg. Primary outcomes of studies A and B are MR-based percent change kidney volume and a composite endpoint of time to 50% reduction of baseline estimated eGFR, ESRD, or death, respectively. Results: This report describes design issues related to (1) novel endpoints such as kidney volume, (2) home versus office BP measures, and (3) the impact of RAAS inhibition on kidney and patient outcomes, safety, and quality of life. Conclusions: HALT PKD will evaluate potential benefits of rigorous BP control and inhibition of the renin-angiotensinaldosterone system on kidney disease progression in ADPKD.

Original languageEnglish (US)
Pages (from-to)102-109
Number of pages8
JournalClinical Journal of the American Society of Nephrology
Volume5
Issue number1
DOIs
StatePublished - Feb 8 2010

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ASJC Scopus subject areas

  • Epidemiology
  • Critical Care and Intensive Care Medicine
  • Nephrology
  • Transplantation

Cite this

Chapman, A. B., Torres, V. E., Perrone, R. D., Steinman, T. I., Bae, K. T., Philip Miller, J., Miskulin, D. C., Oskoui, F. R., Masoumi, A., Hogan, M. C., Winklhofer, F. T., Braun, W., Thompson, P. A., Meyers, C. M., Kelleher, C., & Schrier, R. W. (2010). The HALT polycystic kidney disease trials: Design and implementation. Clinical Journal of the American Society of Nephrology, 5(1), 102-109. https://doi.org/10.2215/CJN.04310709