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Polycystic Kidney Disease Treatment Network (PKD-TN)
CRISP and HALT PKD Clinicial Trials

http://www.pkd.wustl.edu/pkd-tn/

Polycystic Kidney Disease Background

As many as half a million people in the United States and 4 to 6 million world-wide are estimated to have polycystic kidney disease (PKD). PKD is a common inherited condition characterized by cysts that grossly distort the kidneys and liver and by high blood pressure and brain aneurysms (bulges in arteries). In autosomal dominant PKD, the most common form, symptoms usually appear between the ages of 30 and 40 and include back and side pain and headaches. Half of patients develop kidney failure, on average around age 54; 23,000 were on dialysis or had a transplant for kidney failure in 2003, making it this country’s fourth leading cause of kidney failure.

PKD CRISP Project Description

The Consortium for Radiological Imaging Studies of Polycystic Kidney Disease (CRISP) enrolled 241 patients, ages 15 to 46 years, with autosomal dominant PKD and normal to mild losses in kidney function (stage 1 or 2). Researchers in the Electronic Radiology Laboratory (ERL) at Washington University in St. Louis, MO developed MRI techniques to reliably and accurately produce 3-dimensional (3D) images from which cysts and kidneys could be measured. Changes in cyst and kidney volume were compared to standard blood and urine tests of kidney function to identify correlations.  ERL was responsible for collecting the MR images from each of the 4 patient recruitment sites via the internet, making the 3D kidney and cyst volume measurements, and archiving the data.  The CRISP study was completed in 2005.

PKD HALT Project Description

The Polycystic Kidney Disease Treatment Network (PKD-TN) has established the HALT PKD clinical trials to test interventions that may be effective in slowing kidney growth in patients suffering from polycystic kidney disease. HALT PKD was designed to investigate whether a combination of blood pressure medication, combined with controlling blood pressure, will slow the rate of kidney growth in PKD patients as compared to current treatment methods.  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 30-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first two years. Participants enrolled in Study A will be followed for a total of four years, while those enrolled in Study B will be followed for four-to-six years, with the average length of follow-up being five years.  The primary outcome of Study A is the percent change in the total kidney volume measured by magnetic resonance imaging (MRI).  ERL is responsible for collecting the MR images from each of the seven patient recruitment sites via the internet and archiving the data. 

Goals

To support the current PKD HALT project by being the central repository for receiving the kidney images from the seven recruitment sites.

Affiliations and Support for Projects

The studies were supported by cooperative agreements (DK56934, DK56956, DK 56957, and DK 56961) with the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, and the general clinical research centers at the participating patient recruitment institutions.

Published Papers

CRISP Publications
July 6, 2006

  1. Bae KT, Commean PK, Lee JR: Volumetric Measurement of Renal Cysts and Parenchyma using MRI: Phantoms and Patients with Polycystic Kidney Disease. Journal of Computer Assisted Tomography 24:614-619, 2000
  2. Bae KT, Commean PK, Lee JR, Suh JD, Brunsden BS: Development of Image Analysis Methodology for Volumetric Measurement of Renal Cysts and Parenchyma using MRI. Radiology (P) 221:318, 2001
  3. Bae K, Brummer M, Kenney P, King BF, Wetzel LH: MR Imaging to Assess the Progression of Polycystic Kidney Disease: Work in Progress. Radiology 221 (P):317, 2001
  4. Bae K, Chapman A, Grantham J, Torres V, Guay-Woodford L, Klahr S, Miller J: Progression of Polycystic Kidney Disease (PKD) Evaluated by MR Imaging, in American Society of Nephrology 35th Annual Meeting and Scientific Exposition, Philadelphia, PA, 2002
  5. Bae K, Suh JD, Baumgarten D, Kenney PJ, King BF, Wetzel LH, Chapman A, Grantham J, Torres V, Guay-Woodford L, Glockner J, Commean PK, Brummer M, Miller JP: MR Imaging to Assess the Progression of Polycystic Kidney Disease: Baseline and On-going Follow-up Study. Radiology 225 (P):442, 2002
  6. Bae K, Baumgarten D, Kenney P, King BF, Wetzel LH, Chapman A, Grantham J, Torres V, Guay-Woodford L, Glockner J, Commean P, Brummer M, Miller J: MR Imaging to Assess the Progression of Polycystic Kidney Disease: One-year Follow-up Study (abstr). in Radiological Society of North America scientific assembly and annual meeting program, Oak Brook, IL, Radiological Society of North America, 2003, p 469
  7. Bae K, Baumgarten D, Kenney P, King BF, Wetzel LH, Zhu F, Chapman A, Grantham J, Torres V, Guay-Woodford L, Glockner J, Commean P, Brummer M, Klahr S, Thompson P, Miller J, CRISP: MR Imaging to Assess the Progression of Polycystic Kidney Disease: Two-year Follow-up Study (abstr), in Radiological Society of North America scientific assembly and annual meeting program, Oak Brook, Il, Radiological Society of North America, 2004, p 427
  8. Bae K, Zhu F, Chapman A, Grantham J, Torres V, Guay-Woodford L, Bennett W, Klahr S, Miller J: MRI-based Volumetric Evaluation of Complex Cysts in Patients with ADPKD (P). Journal of the American Society of Nephrology 15:221A, 2004
  9. Bae K, Zhu F, Baumgarten D, Kenney PJ, King BF, Wetzel LH: MRI-based Volumetric Evaluation of Complex Cysts in Patients with Autosomal Dominant Polycystic Kidney Disease (abstr). Radiological Society of North America scientific Assembly and Annual Meeting Program. Oak Brook, IL, Radiological Society of North America:249, 2005
  10. Bae K, Zhu F, Chapman A, Torres V, Grantham J, Guay-Woodford L, Baumgarten D, King BF, Wetzel LH, Kenney P, Brummer M, Bennett W, Klahr S, Meyers C, Zhang X, Thompson P, Miller J: Magnetic Resonance Imaging (MRI) Evaluation of Hepatic Cysts in Early Autosomal-Dominant Polycystic Kidney Disease (ADPKD): The Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) Cohort. Clinical Journal of American Society of Nephrology 1:64-69, 2006
  11. Brummer M, Dambreville S, King BF, Chapman A, Glockner J, Torres V, Wallin A, Bae K, Frakes D, Yoganathan A, CRISP: Renal Flow Measurement by Breath-Hold Phase-Velocity MRI: A Validation Study, in International Society of Magnetic Resonance in Medicine 13th Scientific Meeting, Miami Beach, Florida, 2005
  12. Chapman A, Guay-Woodford L, Grantham J, Torres V, Kimmel P, Hirschman G, Miller J, Bae K: Magnetic Resonance Imaging (MRI) in Early Autosomal Dominant Polycystic Kidney Disease (ADPKD): Baseline characteristics of the Consortium for Radiographic Imaging Studies of Polycystic Kidney Disease (CRISP) Cohort (abstr). Journal of the American Society of Nephrology 13:507A, 2002
  13. Chapman A, Guay-Woodford L, Grantham J, Torres V, Bae K, Baumgarten D, Kenney P, King BF, Glockner J, Wetzel LH, Brummer M, O'Neill WC, Robbin M, Bennett W, Klahr S, Hirschman G, Kimmel P, Thompson P, Miller J: Renal Structure in Early Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) Cohort. Kidney International 64:1035-1045, 2003
  14. Chapman A, Torres V, Grantham J, Guay-Woodford L, Ladson J, Thompson P, Miller J, Bae K: Determinants of Development of Hypertension (HBP) in Autosomal Dominant Polycystic Kidney Disease (ADPKD): Observations from the CRISP Consortium (P). Journal of the American Society of Nephrology 15:657A, 2004
  15. Chapman A, Torres V, Grantham J, Guay-Woodford L, Ladson J, Thompson P, Miller J, Bae K: Change in Renal (RV) and Cyst (CV) Volume Early in Hypertensive (HBP) and Normotensive (NBP) Autosomal Dominant Polycystic Kidney Disease (ADPKD) (P). Journal of the American Society of Nephrology 15:656A, 2004
  16. Chapman A, Grantham J, Guay-Woodford L, Torres V, Bae K, Miller J, Meyers C: Progression of Renal Disease in Hypertensive (HBP) ADPKD Subjects Utilizing MR: The CRISP Consortium (P). Journal of American Society of Nephrology 16:359A, 2005
  17. Davila J, King B, Glockner J: Cine Phase Contrast Measurement of Renal Blood Flow as a Marker of Disease Progression in Autosomal Dominant Polycystic Kidney Disease (CRISP), in European Uroradiology/American Genitourinary Radiology, 2002
  18. Glockner J, King BF, Torres V: Cine Phase Contrast Measurement of Renal Blood Flow as a Marker of Disease Progression in Autosomal Dominant Polycystic Kidney Disease, in International Society of Magnetic Resonance in Medicine, 2002
  19. Grantham J, Torres V, Chapman A, Guay-Woodford L, Bae K, King BF, Wetzel LH, Baumgarten D, Kenney PJ, Harris P, Klahr S, Meyers C, Miller J: Volume Evolution: A New Concept for Monitoring Disease Progression in ADPKD. Journal of American Society of Nephrology 16:36A, 2005
  20. Grantham J, Torres V, Chapman A, Guay-Woodford L, Bae K, King BF, Wetzel LH, Baumgarten D, Kenney P, Harris P, Klahr S, Bennett W, Hirschman G, Meyers C, Zhang X, Zhu F, Miller J: Volume Evolution: A New Concept for Monitoring Disease Progr4ession in Autosomal Dominant Polycystic Kidney Disease. New England Journal of Medicine 354:2122-2130, 2006
  21. Guay-Woodford L, Chapman A, Grantham J, Torres V, Bae K, Thompson P, Miller J, Meyers C, Harris P: Renal Disease Progression Varies Within and Among ADPKD Families: The CRISP Consortium (P). Journal of American Society of Nephrology 16:357A, 2005
  22. Harris P, Bae K, Rossetti S, Torres V, Grantham J, Guay-Woodford L, King BF, Wetzel LH, Baumgarten D, Kenney P, Consugar M, Klahr S, Bennett W, Meyers C, Zhang Q, Thompson P, Zhu F, Miller J: Cyst number, but not the rate of cystic growth, is associated with the mutated gene in ADPKD. Nature Medicine In Press, 2006
  23. Hatfield E, Bae K, Zhu F, Commean P, Klahr S, Miller J: Kidney Volume Measurements in PKD using MRI: Comparison of Ellipsoidal, Boundary-tracing and Stereology Methods (abstr). in Radiological Society of North America scientific assembly and annual meeting program, Oak Brook, IL, Radiological Society of North America, 2003, p 531
  24. King BF, Torres V, Glockner J, Chapman A, Bae KT, CRISP: Magnetic Resonance Measurements of Renal Blood Flow as a Marker of Disease Progression in Autosomal Dominant Polycystic Kidney Disease (abstr). Journal of the American Society of Nephrology 12:538A, 2001
  25. King BF, Torres V, Brummer M, Chapman A, Glockner J, Bae KT: Magnetic Resonance Measurements of Renal Blood Flow as a Marker of Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD), Baseline Characteristics (abstr). Journal of the American Society of Nephrology 13:506A, 2002
  26. King BF, Torres V, Brummer M, Chapman A, Bae K, Glockner J, Arya K, Felmlee J, Grantham J, Guay-Woodford L, Bennett W, Klahr S, Hirschman G, Kimmel P, Thompson P, Miller J, CRISP: Magnetic Resonance Measurements of Renal Blood Flow as a Marker of Disease Severity in Autosomal Dominant Polycystic Kidney Disease. Kidney International 64:2214-2221, 2003
  27. Moore S, Maffitt D, Blaine G, Bae KT: A Workstation Acquisition Node for Multi-center Imaging Studies, in Medical Imaging 2001: PACS and Integrated Medical Information Systems: Design and Evaluation (vol 4323), edited by Siegel E, Huang H, San Diego, California USA, SPIE - The International Society for Optical Engineering, 2001, pp 271-277
  28. O'Neill WC, Robbin M, Bae KT: Comparison of Ultrasound (US) and Magnetic Resonance (MR) Imaging for Measurements of Renal Size and Cyst Involvement in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (abstr). Journal of the American Society of Nephrology 13:506A, 2002
  29. O'Neill WC, Robbin M, Bae K, Baumgarten D, King BF, Wetzel LH, CRISP: Sonographic Measurement of the Progression of Autosomal-Dominant Polycystic Kidney Disease (ADPKD): the Consortium for Renal Imaging Studies of Polycystic Kidney Disease (CRISP) (P). Journal of American Society of Nephrology 14:108A, 2003
  30. O'Neill WC, Robbin M, Bae K, Grantham J, Chapman A, Guay-Woodford L, Torres V, King BF, Wetzel LH, Thompson P, Miller J: Sonographic Assessment of the Severity and Progression of Autosomal-Dominant Polycystic Kidney Disease: the Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP). American Journal of Kidney Disease In Press, 2005
  31. Rossetti S, Torres V, Chapman A, Grantham J, Guay-Woodford L, Thompson P, Miller J, Bae K, Harris P, CRISP: Comparison of Gene Type and Progression of Renal Disease in the CRISP ADPKD Population (P). Journal of the American Society of Nephrology 15:655A, 2004
  32. Rossetti S, Torres V, Chapman A, Grantham J, Guay-Woodford L, Miller J, Consugar M, Zhang X, Thompson P, Bae K, Harris P, CRISP: Comparison of Renal Disease in PKD1 and PKD2 CRISP Patients (P). Jouranl of American Society of Nephrology 16:357A, 2005
  33. Rule A, Torres V, Chapman A, Grantham J, Guay-Woodford L, Bae K, Klahr S, Bennett W, Meyers C, Thompson P, Miller J: Predictors of Renal Function Decline in Autosomal Dominant Polycystic Kidney Disease: A Comparison of Methods (P). Journal of the American Society of Nephrology 16:319A, 2005
  34. Rule A, Torres V, Chapman A, Grantham J, Guay-Woodford L, Bae K, Klahr S, Bennett W, Meyers C, Thompson P, Miller J: Comparison of Methods for Determining Renal Function Decline in Early Autosomal Dominant Polycystic Kidney Disease: The Consortium of Radiologic Imaging Studies of Polycystic Kidney Disease Cohort. Journal of American Society of Nephrology 17:854-862, 2006
  35. Thompson PA, Littlewood S, Adelman AJ, Miller JP: The Web Data Entry System: Methods for Web Development and SAS Data Management, in SAS Users Group International, 2002
  36. Torres V, King BF, Chapman A, Brummer M, Bae K, Glockner J, Arya K, Thompson P, Miller J, CRISP: Predictive Value of Renal Hemodynamic Parameters on Kidney Volume and Glomerular Filtration Rate (GFR) Changes in Early ADPKD (P). Journal of American Society of Nephrology 14:108A, 2003
  37. Torres V, Wang X, Ward C, Grantham J, Chapman A, Guay-Woodford L, Bae K, Thompson P, Miller J, CRISP: Urine Cyclic AMP and Aquaporin2 in Early Autosomal Dominant Polycystic Kidney Disease (P). Journal of the American Society of Nephrology 15:221A, 2004
  38. Torres V, King BF, Chapman A, Brummer M, Bae K, Glockner J, Rizk D, Thompson P, Miller J, CRISP: Renal Blood Flow (RFB) Declines Earlier than Glomerular Filtration Rate (GFR) and Predicts Structural and Functional Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (abstr). Journal of the American Society of Nephrology 15:13A, 2004
  39. Torres V, King BF, Chapman A, Brummer M, Bae K, Glockner J, Arya K, Felmlee J, Grantham J, Guay-Woodford L, Bennett W, Klahr S, Meyers C, Zhang X, Thompson P, Miller J: Magnetic Resonance Measurements of Renal Blood Flow and Disease Progression in Autosomal Dominant Polycystic Kidney Disease. In Press, 2006
  40. Wallin A, Frakes D, Brummer M, Yoganathan A, Chapman A: Improvements in Validation Studies: Polyvinyl Alcohol (PVA) Phantoms and Magnetic Resonance Imaging, in Biomedical Engineering Society (BMES), 2003
  41. Wetzel LH, King BF, Kenney PJ, Bae KT, Baumgarten D, Grantham J: Magnet Resonance Angiography Findings in Autosomal Dominant Polycystic Kidney Disease (abstr). Journal of the American Society of Nephrology 12:548A, 2001
  42. Zhu F, Baumgarten D, Kenney P, King BF, Wetzel LH, Bae K: Hepatic Cyst Volume Measurement in PKD using MRI in  CRISP Cohort (abstr). in Radiological Society of North America scientific assembly and annual meeting program, Oak Brook, IL, Radiological Society of North America, 2003, p 531
  43. Zhu F, Bae K, Grantham J, Chapman A, Torres V, Guay-Woodford L, Klahr S, Miller J: MRI of Liver Cysts Volume with PKD (P). Journal of American Society of Nephrology 14:108A, 2003
  44. Zhu F, Baumgarten D, Kenney P, King BF, Wetzel LH, Bae K, Chapman A, Grantham J, Torres V, Guay-Woodford L, Glockner J, Commean P, Brummer M, Klahr S, Thompson P, Miller J, CRISP: Hepatic Cyst Volume Measurement in PKD Using MRI in  CRISP Cohort: One-year Follow-up Study (abstr), in Radiological Society of North America scientific assembly and annual meeting program, Oak Brook, IL, Radiological Society of North America, 2004, p 427
  45. Zhu F, Guay-Woodford L, Bae K, Chapman A, Grantham J, Torres V, Klahr S, Thompson P, Miller J: Prevalence and the Effect of Estrogen on ADPKD Hepatic Cystic Disease (P). Journal of the American Society of Nephrology 15:657A, 2004
  46. Zhu F, Bae K, Chapman A, Grantham J, Torres V, Guay-Woodford L, Klahr S, Zhang X, Miller J, Meyers C: Volumetric Changes in the Liver and Liver Cysts in ADPKD Subjects: The CRISP Consortium (P). Journal of American Society of Nephrology 16:360A, 2005

Links to Other Sites

  1. Polycystic Kidney Disease Treatment Network, HALT PKD - http://www.pkd.wustl.edu/pkd-tn/
  2. PKD Foundation - http://www.pkdcure.org/site/PageServer?pagename=mn_haltpkdtrials
  3. NIH News - Polycystic Kidney Disease: NIH and PKD Foundation Launch HALT-PKD Treatment Trials - http://www.nih.gov/news/pr/jan2006/niddk-24.htm
  4. Clinical Trials.gov - http://www.clinicaltrials.gov/ct/show/NCT00283686
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