Driving Success for Nephrology Clinical Trials
With decades of experience conducting phase I-IV nephrology clinical trials, Medpace is a globally recognized leader in renal clinical research. We understand the complexities of renal disease trials from the perspective of the Sponsor, the clinical investigator, the scientific leader, and the reviewer at regulatory agencies. Our seasoned medical in-house nephrologists, operational, and regulatory teams are fully embedded throughout your project – providing unmatched support for your program. In addition to therapeutically specialized, full-service CRO offerings, Medpace provides comprehensive and fully integrated global central lab services, a bioanalytical lab, an imaging core lab, an ECG core lab, and a Phase I unit. The built-in collaboration and efficiencies of working with a single vendor facilitates a streamlined strategy for executing trials of all sizes and scope.
Making the Complex Seamless in Nephrology Clinical Development
Nephrology CRO Expertise
Medpace brings global experience in kidney disease trials, spanning early to late-phase studies. Our strong site network and KOL relationships accelerate development and enhance patient recruitment – even in hard-to-enroll populations. We’ve successfully led Phase III studies (several to regulatory approval) in key indications such as:
- Acute kidney injury (AKI) and chronic kidney disease (CKD), including diabetic kidney disease (DKD), renal anemia, hypertension and more
- Genetic & rare kidney diseases (e.g., Alport syndrome , hyperoxaluria and autosomal dominant hypocalcaemia)
- Glomerulonephritis (e.g., ANCA vasculitis, IgA nephropathy, C3 glomerulonephritis, lupus nephritis, focal and segmental glomerulosclerosis (FSGS) and primary membranous nephropathy (PMD))
- Renal transplantation (e.g., Allograft rejection, including antibody mediated rejection (AMR), CMV and BK virus post transplantation and cell therapies for improved allograft outcomes)
- Critically ill and ICU patient populations, including complex studies in hospitalized settings
Our scientifically-driven approach embeds therapeutic expertise throughout trial design and execution. Recognizing that renal patients often have comorbidities such as cardiovascular disease, diabetes, and obesity, our dedicated nephrology team collaborates closely with in-house experts in these areas throughout your study – providing a holistic, integrated perspective for complex studies.
Optimized Site Selection with Proven Partnerships
Accelerate your nephrology trials through Medpace’s data-driven feasibility strategy and strong site relationships. Our IntelliPACE® model synthesizes internal and external data sources to pinpoint the most suitable countries and sites, while our dedicated patient recruitment and retention team ensures expedited enrollment and reduced dropouts.
Further enhance your site selection through Medpace Flagship Sites – an established group of top performing global sites and site networks with a proven track record of delivering timely, quality outcomes. Our deep, long-standing relationships with these sites, along with preferred partnerships with key site networks in the U.S. and Europe, streamline study start-up, enhance patient recruitment, and ensure high-quality data capture. Regular engagement with site leaders keeps studies running efficiently while maintaining Medpace’s high standards for study execution.
Comprehensive Lab Support
Innovation and science drive our Sponsor’s R&D pipeline, demanding deep knowledge and expertise. Medpace Central Laboratories bring unmatched experience to nephrology testing, seamlessly supporting even the most complex studies. With four wholly-owned labs in the US, Europe, China, and Singapore, our central lab has the global reach to support studies, assist with regulatory requirements and deliver custom solutions for any need. Combined with Medpace CRO expertise, we provide a fully integrated solution for your clinical development needs.
Relevant Sample Areas Include:
- Chronic Kidney Disease (CKD)
- Acute Kidney Injury
- Autoimmune Disorders
- Inflammation
- Lipids
- Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Endocrine Disorders
- Obesity
Our bioanalytical laboratory further strengthens our capabilities with state-of-the-art instrumentation and expertise in a broad range of small and large molecule bioanalysis. Operating in a GLP-compliant setting, we offer method development, transfer, validation, and analysis of preclinical and biological samples.
Core Imaging and Cardiovascular Safety
Given the importance of accessing cardiovascular risk and cardiovascular monitoring in many nephrology trials, the Medpace ECG Core Laboratory provides yet another layer of integrated efficiency. Our ECG Core Lab has extensive clinical trial experience with complex CT, MR, US and DXA assessments—and their respective analysis and quality control checks. With highly experienced and knowledgeable leadership by physicians and scientists, Medpace offers significant advantages in experience, systems, data integrity, and compliance.
Medpace Offerings Include:
- Board-certified radiologists, nephrologists and cardiologists demonstrating extensive clinical trial experience needed for safety and efficacy assessments
- Widespread knowledge in qualifying sites with customized and advanced data and acquisition protocols
- Specialized project managers experienced in utilizing these modalities specifically for kidney assessment
- Well-versed team in imaging for endocrine and metabolic clinical trials, closely linked to nephrology studies
- Centralized ECG machines and analysis to provide an electronic cardiac safety database
Collaborative & Cross-Functional Teams to Execute Your Nephrology Study
At Medpace, collaboration is at the core of our success in nephrology clinical research. Our integrated teams—spanning medical, regulatory, and operational experts—work seamlessly to provide strategic oversight and execution at every stage of development. This synergy allows us to anticipate challenges, adapt strategies, and drive meaningful advancements in renal disease research. Explore our expert leaders who are shaping nephrology research:
Ajay Srivastava, MD, FASN
Sr. Vice President, Medical Department
Dr. Ajay Srivastava is a board-certified nephrologist with an extensive background in both clinical and academic medicine. Specializing in adult nephrology, he brings over 20 years of experience in both the common and rare conditions of the kidney, renal replacement therapies, ICU nephrology including IV fluid resuscitation and management and comorbid conditions such as cardiorenal syndrome and hypertension. As an interventional nephrologist, he also provided education, assistance and evaluation regarding matters of dialysis vascular access including the performance of interventional procedures to preserve, optimize and salvage these hemodialysis accesses. Dr. Srivastava has also held several other leadership positions including Director of Nephrology Fellowship Training, the Medical Directorship of dialysis facilities, Division Chief of Nephrology and Interim Chair of Medicine, and has served on a number of departmental, hospital and university committees.
Ineta Sosare, MD, PED, NEP
Medical Director
Dr. Sosare is a board-certified nephrologist and pediatrician with more than 20 years of therapeutic expertise gleaned from her roles as a physician and in academia. As consulting nephrologist, Dr. Sosare worked at the University Hospital for Children in Riga, Latvia, where she managed patients with non-surgical urinary tract and acute and chronic renal disorders, kidney transplant, and renal replacement therapy. Furthermore, she has worked in development of clinical guidelines in acute kidney injury, nephrotic syndrome, and hemolytic uremic syndrome.
Candice Clarke, MBBS (Hons), DPM, PhD, MRCP, MFPM
Medical Director
Dr. Clarke is a nephrologist and pharmaceutical physician with an extensive background in both clinical and academic medicine. She brings more than 12 years of therapeutic and clinical trial expertise in nephrology with a focus on immune mediated forms of renal disease, and expertise in renal transplantation. Dr. Clarke is an honorary clinical research fellow at Imperial College London and has experience as an Investigator for clinical studies in renal populations.
Heather Lohr
Therapeutic Group Lead – Nephrology
Executive Director, Clinical Trial Management
Ms. Lohr has a Bachelor of Arts in Physical Anthropology and has over 19 years of operational experience in the clinical research industry with 11 years in clinical trial management at Medpace. Ms. Lohr has been both a CTM and a Lead Clinical Research Associate (CRA) on multiple complicated nephrology (rare renal/glomerular diseases), oncology/hematology, cardiovascular, and rheumatology studies and has supported FDA, EMA and PMDA approval on multiple indications.
Frénel Joseph
Sr. Director, Clinical Trial Management
Mr. Joseph holds a Master’s of Science in cellular biology and physiology and a Certificate of Methodology and Statistics in medical research, DIU CESAM from Pierre & Marie Curie University, Paris VI. He brings 24 years of experience in Lifecycle Management and Project Management of international clinical trials mainly at CROs and Pharma industry. Throughout Mr. Joseph’s career he has successfully managed all clinical development aspects of several global Phase 1-4 clinical research projects from start-up to completion. Mr. Joseph has successfully led global programs in the rare renal/glomerular disease space which have been reviewed and approved by the FDA, EMA, leading to marketing authorization of innovative treatments.
Advancing Glomerulonephritis Clinical Research
Glomerulonephritis encompasses a range of rare but serious kidney disorders, requiring specialized expertise to navigate the complexities of clinical research. Medpace has relevant and recent experience in a broad spectrum of glomerular diseases, including glomerulonephritis associated with ANCA vasculitis, IgA nephropathy, membranous nephropathy, alport syndrome, C3 glomerulonephritis and focal segmental glomerulosclerosis. This experience is further enhanced by our glomerulonephritis working group, a forum consisting of our cross functional leaders highlighting lessons-learned from past trials and creative problem-solving strategies contributing to a track record of success in GN drug development. Our seasoned clinical operations staff bring specific knowledge in conducting renal disease trials with a deep understanding of complicated procedures such as effective collection and processing of 24hr urine samples which are commonly used for primary endpoint analyses in these populations. With a track record of managing phase I-IV studies, Medpace is Trusted by Biotech® to deliver high-quality data and drive breakthroughs in glomerulonephritis treatment.
