Renal function &
Hemodynamic Measurements
At DELPHINIUM, renal function and hemodynamic assessment are a key pillar of our cardio-renal focus. As two independent partnering organizations, DELPHINIUM has a close collaboration with the Department of Nephrology/Groningen Kolff Center (GKC) at the University Medical Center Groningen (UMCG). This allows DELPHINIUM to conduct high-quality early-phase studies integrating the advanced renal expertise of GKC.
Studies are typically conducted in healthy volunteers, but, where justified and feasible, can also include patient populations with chronic kidney disease (CKD) or other stable renal conditions relevant to your compound.
The UMCG Department of Nephrology has a strong international track record in CKD, glomerular disease and renal physiology, with particular expertise in measured GFR and renal hemodynamics. This makes it an ideal environment for early-phase studies that require precise characterization of renal effects.
Collaboration UMCG
In collaboration with the Department of Nephrology, we provide sponsors with direct access to leading nephrology investigators, validated renal measurement techniques, and a large regional patient population.
This collaboration enables sponsors to:
- Execute first-in-human and other Phase I studies in a dedicated, GCP-compliant clinic directly connected to a university medical center
- Integrate sophisticated renal endpoints and hemodynamic assessments into early-phase protocols
- Plan a smooth transition from early-phase safety and PK/PD work to Phase II and beyond within the same academic ecosystem
Hemodynamic assessments
Within our kidney function hemodynamic studies, we can incorporate a range of assessments, depending on your compound’s profile and development questions. These may include:
- Renal blood flow assessment using para-aminohippuric acid (PAH) clearance
- Measured GFR using validated exogenous filtration markers such as Iohexol
- Structural renal imaging (e.g. ultrasound) to support safety and functional readouts
- Estimated GFR based on serum creatinine and/or cystatin C
- Albuminuria and proteinuria (spot or timed interval urine collections)
- Markers of tubular function (e.g. electrolyte handling, tubular injury markers)
- Biomarkers of kidney damage and stress (e.g. NGAL, KIM-1 and other emerging markers)
By embedding these measurements into early-phase protocols, we help sponsors obtain high-resolution data early in development, supporting:
- Characterization of renal safety and tolerability
- Understanding of renal PK/PD relationships
- Exploration of renoprotective or renal hemodynamic effects in CRM populations
Key Opinion Leader
Professor Ron Gansevoort is an internist working at the University Medical Center Groningen and a recognized expert in chronic kidney disease, glomerular and polycystic kidney disease, and renal physiology. Besides working as nephrologist, he also trained as clinical pharmacologist. He worked for several years as rapporteur for the Dutch Medicines Evaluation Board and the European Medicines Agency. His present work spans clinical practice, intervention trials, cohort studies and mechanistic research, with a strong focus on:
- Early detection and progression of CKD
- The role of albuminuria and other biomarkers in kidney disease
- Development of novel treatments for CKD and PKD
In his role as Key Opinion Leader working at the GKC, Professor Gansevoort can:
- Answer content-related questions from sponsors in the field of renal research and renal physiology.
- Provide scientific input for protocol development, including selection of appropriate renal endpoints.
- Advise on optimal PK/PD approaches and the choice of relevant PD markers and/or renal biomarkers (including measured GFR and renal hemodynamic measures), aligned with the compound’s mechanism and development questions.
- Support in the recruitment of a suitable patient population.
