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Article: The HALT polycystic kidney disease trials: Design and implementation

TitleThe HALT polycystic kidney disease trials: Design and implementation
Authors
Issue Date2010
Citation
Clinical Journal of the American Society of Nephrology, 2010, v. 5, n. 1, p. 102-109 How to Cite?
AbstractBackground 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, placebo-controlled 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 m2 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-angiotensin-aldosterone system on kidney disease progression in ADPKD. Copyright © 2010 by the American Society of Nephrology.
Persistent Identifierhttp://hdl.handle.net/10722/316031
ISSN
2023 Impact Factor: 8.5
2023 SCImago Journal Rankings: 2.395
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorChapman, Arlene B.-
dc.contributor.authorTorres, Vicente E.-
dc.contributor.authorPerrone, Ronald D.-
dc.contributor.authorSteinman, Theodore I.-
dc.contributor.authorBae, Kyongtae T.-
dc.contributor.authorPhilip Miller, J.-
dc.contributor.authorMiskulin, Dana C.-
dc.contributor.authorOskoui, Frederic Rahbari-
dc.contributor.authorMasoumi, Amirali-
dc.contributor.authorHogan, Marie C.-
dc.contributor.authorWinklhofer, Franz T.-
dc.contributor.authorBraun, William-
dc.contributor.authorThompson, Paul A.-
dc.contributor.authorMeyers, Catherine M.-
dc.contributor.authorKelleher, Cass-
dc.contributor.authorSchrier, Robert W.-
dc.date.accessioned2022-08-24T15:49:00Z-
dc.date.available2022-08-24T15:49:00Z-
dc.date.issued2010-
dc.identifier.citationClinical Journal of the American Society of Nephrology, 2010, v. 5, n. 1, p. 102-109-
dc.identifier.issn1555-9041-
dc.identifier.urihttp://hdl.handle.net/10722/316031-
dc.description.abstractBackground 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, placebo-controlled 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 m2 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-angiotensin-aldosterone system on kidney disease progression in ADPKD. Copyright © 2010 by the American Society of Nephrology.-
dc.languageeng-
dc.relation.ispartofClinical Journal of the American Society of Nephrology-
dc.titleThe HALT polycystic kidney disease trials: Design and implementation-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.2215/CJN.04310709-
dc.identifier.pmid20089507-
dc.identifier.scopuseid_2-s2.0-75749109803-
dc.identifier.volume5-
dc.identifier.issue1-
dc.identifier.spage102-
dc.identifier.epage109-
dc.identifier.eissn1555-905X-
dc.identifier.isiWOS:000273710200016-

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