Who We Are

The TwoPlus Clinical Trial is funded by Patient-Centered Outcomes Research Institute (PCORI). The study takes place at ten healthcare systems and more than fifty outpatient dialysis units in the United States. The study is conducted in collaboration with patient-led organizations like the American Association of Kidney Patients and Home Dialyzors United.

 

Clinical Coordinating Center

Mariana Murea, MD
Study Principal Investigator

Dr. Murea is a nephrologist and clinical investigator at Wake Forest University School of Medicine \ Atrium Health Wake Forest Baptist Medical Center. Dr. Murea’s research expertise is in kidney disease translational, genetic and clinical studies; and in clinical trials in hemodialysis. Dr. Murea serves as the lead investigator of the TwoPlus Clinical Trial.

Peter Kotanko, MD
Study Co-Principal Investigator

Dr. Kotanko is the Research Director at the Renal Research Institute (RRI) in New York, where he leads research projects in collaboration with Fresenius Medical Care (FMC). Dr. Kotanko is also the co-founder of the MONDO initiative, the world's most diverse international dialysis database. Dr. Kotanko is Co-Principal Investigator in the PCORI-funded TwoPlus Clinical Trial.

Data Coordinating Center

Jasmin Divers, PhD
Study Co-Investigator

Dr. Divers is a biostatistician and Director of the Center of Population and Health Services Research at the NYU Grossman Long Island School of Medicine. Dr. Divers has broad expertise in kidney disease and kidney transplantation epidemiology, genetics and clinical trials. He leads the TwoPlus Data Coordinating Center.

Investigators

Cleveland Clinic Case Western Reserve University

Cassandra Kovach, MD
Site Principal Investigator

Dr. Cassandra Kovach is a Nephrologist at the Cleveland Clinic Foundation and Medical Director of Fresenius Kidney Care. She has over a decade of experience in Internal Medicine and Nephrology. As an Investigator for the PCORI study, she'll oversee dialysis personnel, patient enrollment, and treatment transitions and adherence.

Anne Huml, MD
Site Co-Investigator

Dr. Anne Huml is a nephrologist at the Cleveland Clinic Glickman Urological and Kidney Institute. She is also a clinical researcher at the Case Center for Reducing Health Disparities and.  Her research focuses on improving outcomes for kidney disease patients and reducing barriers of clinical care. She serves on several advisory boards and chairs the Ohio River Valley Transplant Coalition.

Emory University

Dr. Vandana Dua Niyyar

Vandana Dua Niyyar, MD
Site Principal Investigator

Dr. Niyyar is a Professor of Medicine at the Emory University School of Medicine and will be the Site Principal Investigator conducting the TwoPlus study at Emory Dialysis Centers. As a Clinician-Educator, Dr. Niyyar’s focus has been on improving morbidity associated with vascular access in hemodialysis patients, and implementing a pro-active approach with multi-disciplinary interventions to help improve outcomes in patients treated with hemodialysis.

Shawanna Jackson

Shawanna Jackson, MBA, MHA
PCORI Ambassador

Shawanna is the Administrator for Renal Medicine, and will provide overall direction for all administrative, clinical and research operations for the School of Medicine, The Emory Clinic, and our Emory Dialysis Centers. Over the past 10 years, Shawanna has served as an advocate, patient reviewer, and a PCORI Merit Reviewer and Ambassador. Since becoming a PCORI Ambassador, Shawanna has worked closely with researchers in both community and academic health systems, sharing with them the value that PCOR and patient engagement adds to research and the impact it can have in disseminating and implementing study findings.

Janice Irene Phillips Lea, MD, MSc, FASN
Co-Investigator

Dr. Lea is the chief medical director of Emory Dialysis and is a nationally renowned expert in hypertension - designated a "Clinical Specialist in Hypertension" by the American Society of Hypertension. She is also a professor of medicine at Emory University and is board-certified in nephrology and hypertension.

Johns Hopkins University School of Medicine

Samir Gautam, MD
Site Principal Investigator

Dr. Samir Gautam is an Assistant Professor at Johns Hopkins School of Medicine and a Medical Director for the Acute Analysis Unit at Johns Hopkins Hospital. With over 8 years of nephrology experience, he has improved quality care and patient experience in dialysis units. As Site PI at Johns Hopkins, he will oversee participant enrollment, operational processes, data collection, and stakeholder engagement.

Gaurav Raman, MD
Site Co-Investigator

Dr. Raman is a Clinician working in the Division of Nephrology at Johns Hopkins. He will serve as a Co-Investigator in the PCORI TwoPlus study. He will engage with stakeholders, oversee the transition from twice- to thrice-weekly HD, and participate in patient interviews.

Renal Research Institute

Jochen Raimann, MD
Site Principal Investigator

Dr. Raimann earned an MD from Medical University Graz. He later earned his PhD at Maastricht University. He focuses on epidemiologic research and holds positions at RRI, Yeshiva University, CUNY School of Public Health. He will be the Site PI at the Renal Research Institute.

Laura Rosales Merlo, MD, MPH
Co-Investigator

Dr. Rosales earned an MD from the Central University in Quito, Ecuador, and a master’s degree on public health from Columbia University, New York. She is an accomplished scientist with ample experience in clinical research focused on ESKD and PD. Dr. Rosales will serve as the RRI site Co-Investigator in the PCORI TwoPlus study.

University of Florida Jacksonville

Dr. Alaa S. Awad

Alaa S. Awad, MD, MSc, FASN
Site Principal Investigator

Dr. Awad is a Professor of Medicine\Nephrology at the University of Florida Jacksonville. He is the Medical Director of Dialysis Units affiliated with the University of Florida – Jacksonville. Dr. Awad has conducted research focused on both clinical and transitional research for the last 20 years and has a wealth of experience in the practice of incremental hemodialysis. Dr. Awad has the role of Site Principal Investigator and will lead and oversee the implementation of the TwoPlus study at the UF.

 

Irtza Hasan, MD, MSc, MRCP, FASN
Co-Investigator

Dr. Hasan is an Assistant Professor of Nephrology at the University of Florida College of Medicine. His career is marked by extensive involvement in patient-centric & translational research initiatives geared explicitly toward advancing precision medicine and pioneering innovative therapeutic methods. He is deeply committed to advancing Nephrology and personalized therapeutic approaches for advanced renal diseases.

 

Bhaktidevi Makadia, MD
Co-Investigator

Dr. Makadia is an Assistant professor of Nephrology at the University of Florida - Jacksonville campus. Her research interest is improving morbidity and quality of life among dialysis patients. She has over eight years of experience teaching in the field of internal medicine and nephrology. She will serve as site co-investigator for TwoPlus trial.

University of North Carolina, Chapel Hill

Jennifer Flythe, MD
Site Principal Investigator

Dr. Flythe is a nephrologist and clinical investigator at the University of North Carolina (UNC) School of Medicine \ UNC Kidney Center. Dr. Flythe conducts patient-oriented qualitative, epidemiologic, and prospective research aimed at improving outcomes and experiences among individuals with advanced kidney disease. Dr. Flythe will serve as the UNC site Principal Investigator.

Stephanie Pavlovich, MD
Co-Investigator

Dr. Pavlovich is a nephrology fellow at the University of North Carolina in Chapel Hill. Her prior research has focused on immunogenomics. She has a current clinical and research interest in peritoneal dialysis and hemodialysis.

University of Virginia

Emaad Abdel-Rahman, MD
Site Principal Investigator

Dr. Emaad Abdel-Rahman is the director of the main hemodialysis unit at UVA and the Home Hemodialysis Unit. He has extensive clinical research experience. He serves as the Investigator for the UVA site in the PCORI study, overseeing site preparation, study implementation, and participant engagement.

Daphne Knicely, MD
Site Co-Investigator

Dr. Daphne Knicely is an Associate Professor of Medicine at the University Of Virginia School Of Medicine. She's held leadership roles in several clinical trials, and she serves as the medical director for the UVA Staunton Dialysis unit. She is a co-investigator for the PCORI project.

Wake Forest University School of Medicine

Mariana Murea, MD
Principal Investigator

Dr. Murea is a nephrologist and clinical investigator at Wake Forest University School of Medicine \ Atrium Health Wake Forest Baptist Medical Center. Dr. Murea’s research expertise is in kidney disease translational, genetic and clinical studies; and in clinical trials in hemodialysis. Dr. Murea serves as the lead investigator of the TwoPlus Clinical Trial.

Consultant

John Daugirdas, MD

Dr. John Daugirdas is a Clinical Professor of Medicine with over four decades of experience in Nephrology. His research focuses on dialysis therapy measurements and he's Co-Editor of the Handbook of Dialysis. In this PCORI study he serves as consultant to determine the effects of individualized, incrementally-prescribed hemodialysis on dialysis adequacy and solute clearance.

Implementation Sciences Team

Ucheoma Nwaozuru, PhD

Dr. Ucheoma Nwaozuru is an Assistant Professor in Implementation Science at Wake Forest School of Medicine. Her research is focused on community-based research and health equity. In the PCORI study she will focus on implementation and process evaluation, engaging stakeholder partners and study dissemination.

Kristie Foley, PhD

Dr. Kristie Foley is a professor in Implementation Science at Wake Forest School of Medicine. She implements best practices in primary and oncology care to reduce cancer disparities. She partners with stakeholders to implement evidence-based strategies locally and globally. In the PCORI study, her team will monitor adaptations to care processes.

 

Alexandra Peluso

Alexandra Peluso is a behavior change and evaluation expert who applies implementation science methodologies to promote health behaviors, specifically healthy eating and physical activity in children and adolescents, as well as optimize cancer care and cancer survivorship for all. I received my BS in Exercise Science from the University of South Carolina and MS in Health Behavior and Health Education from the University of Texas at Austin."

Stakeholder Partners

Glenda V. Roberts, Nichole M. Jefferson, and Nieltje Gedney (In Memoriam) have partnered with the TwoPlus Research Team. They will assist in the approach to patient and caregiver recruitment, co-lead focus group meetings, and conduct semi-structured questionnaires with patient participant representatives. They will provide unbiased input and operational advice to optimize patient engagement and collaboration with other stakeholders; participate in disseminating the impact of patient participant engagement in this study on intervention implementation and sustainability; and present the results at scientific and lay conferences and on media platforms.

Glenda V. Roberts

Glenda V. Roberts is Director of External Relations & Patient Engagement at UW Kidney Research Institute and UW Center for Dialysis Innovation (CDI). She received the 2022 President's Medal and is involved in numerous kidney health initiatives. A kidney transplant recipient, Glenda has experienced in-center hemodialysis and peritoneal dialysis. Glenda is a Stakeholder Partner in the TwoPlus Clinical Trial.

Nichole M. Jefferson

In 2017, Mrs. Nichole Jefferson joined the Home Dialyzors United (HDU) Board of Directors and was later elected President of the Board. She also became a Field Ambassador for the American Association of Kidney Patients and co-leader of the NIDDK APOLLO Community Advisory Board.

Nieltje Gedney (In Memoriam)

Mrs. Gedney was a tireless advocate for personalized treatment, particularly the incremental dialysis approach. As a hemodialysis patient for nine years and the Executive Director of Home Dialyzors United (HDU), she strongly believed in the importance of a customized prescription that allows the body to adjust gradually to the treatment until a full dose of hemodialysis is necessary.

The American Association of Kidney Patients (AAKP) and the TwoPlus Dissemination Committee

Edward V. Hickey, III

Mr. Hickey is President of the AAKP, Chair of the AAKP Veterans Health initiative, and a chronic kidney disease patient (CKD). Prior to him assuming the role of President, Mr. Hickey held the Secretary and Vice President positions of the organization. Professionally, he is a former Marine infantry officer, and his public service career includes posts on Capitol Hill as an Administrative Assistant in the House of Representatives and service in two presidential administrations. Currently, he is practicing law in Los Angeles. 

Paul T. Conway

Mr. Conway is Chair of Policy & Global Affairs, and past president, of the American Association of Kidney Patients (AAKP), the largest U.S. kidney patient organization. Mr. Conway has advanced the principles of patient consumer care choice, patient-centered care and greater use of patient insight data in research and innovation across the federal government and, globally, before the United Nations, the European Parliament and the World Health Organization.

Diana Clynes

Diana Clynes serves as the Executive Director for the American Association of Kidney Patients (AAKP). In her role, she leads the implementation and execution of AAKP's national strategy and mission. Diana is responsible for managing funding contracts, cultivating relationships with industry, government and organizational partners, and representing AAKP on renal-related committees, coalitions and workgroups at state and national levels. Diana works closely with the Board of Directors and Executive Leadership Committee to develop program metrics, analyze results and ensure that the Association's mission, goals, and objectives are met or exceeded. Diana holds a Bachelor's Degree in Mass Communications with an emphasis in Public Relations, as well as a minor in Business. Diana has been with AAKP since 2005.

Erin Khale

Erin Kahle joined AAKP in April 2017 as Director of Stakeholder Operations for AAKP’s Center for Patient Engagement & Advocacy. Her primary responsibilities included establishing a national network of patient ambassadors and encouraging patients and family members to be engaged in various awareness, advocacy, and research opportunities to ensure their voices are heard, and improvements are made in kidney care. In 2023, Erin became Deputy Director to further support the Executive Director and continue building relationships with potential partners across industry, government, and nonprofit.  She will continue her focus on enhancing AAKP’s Ambassador Initiative that she created in 2017 and overseeing the planning and execution of all AAKP programs and events.

Jennifer Rate

Jennifer joined AAKP in 2020 as Marketing and Communications Manager and took on the role of Director of Communications and Digital Operations in 2023. She is responsible for the organization’s social media strategy, branding, marketing, publications, and public relations efforts. Her tasks include managing and creating social media content, graphic design, overseeing aakp RENALIFE and e-newsletters, website content, and development activities. Jennifer also heads clinical trial and educational awareness campaigns from a marketing/recruitment perspective, develops strategies to leverage resources from private, non-profit, and government sources in support of established goals and objectives, and works to maintain strong communications among stakeholders in the development process. In 2023, Jennifer became Director of Communications and Digital Operations.

DSMB Members

 

 

Tariq Shafi, MD, MHS-Nephrologist

Acting Professor of Medicine, Academic Institute Head, Division of Kidney Diseases, Hypertension & Transplantation, Department of Medicine Houston Methodist

Dr. Shafi is an NIH-funded clinician-scientist focusing on cardiovascular risk factors and outcomes in patients with kidney disease treated with dialysis. Dr. Shafi has extensive expertise in human subjects clinical research, biomarker studies, health services research, and population health. He has been continuously funded by NIH since 2006. Dr. Shafi is a permanent member of the NIH Health Services Quality and Effectiveness (HSQE) Study Section and is a member of the editorial boards of the Clinical Journal of the American Society of Nephrology, the American Journal of Medical Sciences, and Kidney360.

 

Finnian McCausland, MBBCh, MMSc, FRCPI, PG CertMedEd- Nephrologist

Dr. Finnian R. Mc Causland is an assistant professor of medicine, faculty director in Postgraduate Medical Education and co-director of the Master of Medical Sciences in Clinical Investigation program at Harvard Medical School. He is also an associate physician and attending nephrologist at Brigham and Women's Hospital (BWH). Dr. McCausland's major research interests relate to the cardiovascular consequences associated with hemodialysis and risk factors for progression of chronic kidney disease. He graduated from Harvard Medical School with a Master’s in Medical Science Degree in Clinical Investigation in 2012 and has received competitive funding from the Irish Nephrology Society, American Heart Association, National Kidney Foundation and National Institutes of Health. He is the principal investigator of two ongoing randomized controlled trials related to the dialysate prescription and its effect on hemodynamic stability.

 

Daniel E. Weiner, MD, MS-Nephrologist

Associate Medical Director, Dialysis Clinic, Inc., Boston; Associate Professor, Tufts University School of Medicine

Dr. Weiner is the recipient of an award from PCORI to evaluate decision-making in advanced kidney diseases. He is the prior recipient of an R01 from the NIDDK investigating the role of exercise on vascular disease, physical function and cognitive function in people with chronic kidney disease. He previously completed a K23 Career Development Award from the NIDDK investigating cerebrovascular disease and cognitive impairment in individuals with CKD. He is the local principal investigator in multiple clinical trials evaluating people with chronic kidney disease, including the NIH-funded SPRINT trial, investigating optimal blood pressure targets in older adults with cardiovascular disease or CKD.

Dr. Weiner also conduct research in the dialysis population, examining dialysis practices, and he is the national principal investigator for a large pragmatic clinical trial evaluating nutritional supplements in hemodialysis patients. Other ongoing research evaluates cognitive impairment and cerebrovascular disease in dialysis patients. He also is collaborating with researchers at Boston University and in Nicaragua to investigate causes of epidemic CKD in Central America.

 

Kaleab Z. Abebe, PhD- Biostatistician

• Assistant Vice Chancellor for Clinical Trials, Health Sciences
• Professor of Medicine with Tenure
• Associate Professor of Biostatistics and Clinical and Translational Science
• Director, Center for Research on Health Care Data Center (CRHC-DC)
• Director, Center for Clinical Trials and Data Coordination (CCDC)

Dr. Abebe's collaborative research focuses on design, conduct, coordination, and analysis of multicenter randomized controlled trials (RCTs). He is the PI of two large NIH-funded consortiums: the COPE-AKI Consortium Scientific & Data Research Center, which is developing and testing interventions to reduce morbidity and mortality in AKI survivors; and the Data Coordinating Center (DCC) for the REBIRTH Study, which will assess the effect of bromocriptine on left ventricular ejection fraction in women with peripartum cardiomyopathy. He is the Co-PI for the CaRISMA study, which is a pragmatic trial examining the effectiveness of computerized cognitive behavioral therapy (vs pain education) on pain intensity in adults with sickle cell disease (SCD). Dr. Abebe’s methodological interests revolve around the design and analysis of cluster randomized trials. In addition to his research collaborations, Dr. Abebe is the director of the Clinical Trials Track for the MS in Clinical Research at the Institute for Clinical Research Education. He is a standing member of the Kidney, Endocrine, and Digestive Disorders (KEDD) Study Section, and he is a member of the Board of Directors and chair of the Equity, Diversity, and Inclusion committee for the Society for Clinical Trials.

 

Paul T. Conway

Mr. Conway is Chair of Policy & Global Affairs, and past president of the American Association of Kidney Patients (AAKP), the largest U.S. kidney patient organization. Mr. Conway has advanced the principles of patient consumer care choice, patient-centered care, and greater use of patient insight data in research and innovation across the federal government and, globally, before the United Nations, the European Parliament, and the World Health Organization.

 

Fiona McKinney-Patient Ambassador

Fiona is an active AAKP Ambassador who got involved as a kidney advocate to ensure better health coverage for dialysis and transplant patients, including coverage for kidney transplant medications (immunosuppressants) and post-transplant care.

 

Yalonda Moore-Caregiver Ambassador

In February 2018, Yalonda was asked to join the NPFE-LAN Team. She has been a member as a SME for Caregivers/Care Partners. Both Gary and Yalonda have participated in several podcasts as well as educational review panels. They love talking about the benefits of doing PD and traveling while on PD as well as talking to people about how to involve your children in your treatment and being your own first defense during your treatment.