Closeout of the HALT Polycystic Kidney Disease Treatment Network Trials

Transcription

1 Closeout of the HALT Polycystic Kidney Disease Treatment Network Trials Society for Clinical Trials Philadelphia, PA Monday, May 19, 2014 Charity G. Moore, PhD Susan Spillane, RN, CCRP Marie Hogan, MD, PhD

2 HALT PKD Study A and Study B Study A: To study the efficacy of ACE-I/ARB combination therapy as compared to ACE-I monotherapy, and usual vs. low blood pressure targets, on disease progression. NCT Study B: To study the efficacy of ACE-I/ARB combination therapy as compared to ACE-I monotherapy on disease progression. NCT

3 Screening and Eligibility Study A Age yrs egfr>60 mls Study B Age yrs egfr mls Study A Low vs Standard BP ACE ± ARB N=558 Study B Standard BP ACE ± ARB N=486 PCC visits Q6 months 7 sites, DCC, central labs, central imaging center Original Extended

4 SYSTOLIC STUDY A LOW 5-8 years of BP control PCC visits Q6 months Open label and masked drug -- 9 steps STUDY A STND

5 MOP Chapter 17 in 2012

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7 The Closeout Committee was formed! The objective of the closeout is to ensure a safe, organized, timely closeout at all levels of the HALT- PKD clinical trial including the participant level, the PCCs and the DCC.

8 APPROVAL DECEMBER wk

9 June 30, 2013: First penultimate visit

10 Results (n=389) 99.5% completed Form 2 Contact Info 87% have PCP/nephrologist to transfer care 94% will have established insurance 99.7% want to receive their study results 99.5% want to know study arm 32% PCP final letter; 60% Nephrologist

11 December 2012: Looking ahead. June 30, 2013: December 30, 2013: June 30, 2014: September 1, 2014 October 1, 2014 November 11, 2014 December 1, 2014 First penultimate visit First closeout visit Last closeout visit Preliminary data lock Data lock ASN HALT-PKD presentation Unblinding

12 DCC Tasks included Table: Remaining Number of Visits by Calendar Month for Study A Full Participants Emory Kansas Mayo Tufts Beth Israel Cleveland Colorado Nov Dec Jan Feb Mar Apr May Jun

13 80mg taper reports-gauging degree of taper by month during closeout schedule Projected Penult and COV with MRIs

14 Unblinding and Releasing Study Results: Just me and admin

15 Closeout PCC: GCP Milestones All participants off protocol Pharmacy and drug destruction Laboratory and repository shipments Blood, urine, genetic samples Imaging Center

16 DCC Responsibilities Data cleaning Final monitoring visits Publications Clinicaltrials.gov Data sharing hive_requirements/ Budget for this!

17 Data Cleaning 2013 Study A Source and Time points Measure 1 Total Kidney Volume MRI Baseline, 24, 48, 60 months 2 egfr Centrally processed serum creatinine F5-F72 2 Renal blood flow MRI Baseline, 24, 48, 60 months 2 Left ventricular mass MRI Baseline, 24, 48, 60 months 2 Albuminuria 24-hour urine Baseline, F12, F24, F36, F48, F60, F72 2 Aldosterone 24-hour urine Baseline, F12, F24, F36, F48, F60, F72 2 Hospitalizations Form 5, Q4 Form 30 SAEs 2 Adverse events Form 5 SAEs 2 Quality of life Form 38 Baseline, F12-F84 Q6 months 2 Pain Form 39 Baseline, F12-F84 Q6 months

18 PCC Final Monitoring Visits Schedule

19 Primary Publications First authors finish intro & methods: June 15, 2014 Last participants to be seen: June 30, 2014 Results sent to first and last authors: July 1, 2014 Distribution of draft to co-authors: July 21, 2014 Draft to Boeringer Ingelheim: August 5, 2014 Preliminary database lock: Sept Submission to NEJM: Sept 9, 2014 Submission to ASN: Sept 17, 2014 Final database lock: Oct 1, 2014 American Society Nephrology: Nov 11-16, 2014

20 Staffing The Human Factor Turnover New studies Retirement Administrative support Saying good-bye Participants

21 Acknowledgements: Sponsored by: NIH NIDDK-grant #: U01-DK082230, Dr. Michael Flessner, Project Scientist Polycystic Kidney Disease Foundation (PKD Foundation) Boehringer-Ingelheim (supplier of study drug-telmisartan) Merck Corporation (supplier of study drug-lisinopril) Principal Investigators and Institutional Support: Dr. Robert Schrier University of Colorado Anschutz Medical Campus Dr. Vicente Torres Mayo Clinic Dr. Ronald Perrone Tufts Medical Center Dr. Arlene Chapman Emory University Dr. Ted Steinman Beth Israel Deaconess Medical Center Dr. William Braun Cleveland Clinic Foundation Dr. Charity Moore University of Pittsburgh DCC Dr. Franz Winklhofer University of Kansas Medical Center Dr. Ty Bae University of Pittsburgh, Imaging Analysis Center

22 Questions? Charity G. Moore, PhD Susan Spillane, CCRP