Renal Impairment Studies
Our Special Population Capabilities
Renal Impairment
Studies
Hepatic Impairment
Studies
Other Special
Populations
Renal Impairment Studies – Porto, Portugal
Critical Data for the Registrational Pathway
Renal impairment profoundly affects the pharmacokinetics (PK) and pharmacodynamics (PD) of investigational drugs. Both EMA and FDA require renal impairment studies in the registrational pathway for most new drugs, to guide dose adjustment and inform the product label.
At Astrum, we specialize in conducting these complex studies with scientific rigor, patient safety, and regulatory credibility at the forefront. Our 60-bed hospital-based Phase I unit in Porto, supported by direct access to onsite dialysis unit and a 11-hospital clinical research network, provides seamless access to patients across the full spectrum of renal function. Our hospital network we have dedicated Dialysis units.
Our Capabilities in Renal Impairment Studies
Full Spectrum of Renal Impairment Cohorts
Mild, moderate, severe, and end-stage renal disease (ESRD) patients included.
Dialysis Studies
Trials designed around dialysis schedules, including timing of dose, comparative cohorts, and drug clearance evaluation.
Flexible Study Designs
Dose titration, crossover protocols, multiple formulations, and blinded/unblinded designs tailored to Sponsor needs.
Dedicated Nephrology Oversight
On-site specialists ensure both participant safety and data integrity.
Successful Experience
We are experienced in the conduct of renal impairment trials with a proven track record of competitive recruitment and regulatory-ready timelines.
Why Renal Studies Matter
Dose Adjustment
Establish safe and effective dosing regimens for impaired patients.
Labeling Strategy
Generate the mandatory data required for regulatory labeling.
Risk Mitigation
Identify potential safety issues before late-phase or market entry.
Regulatory Alignment
Meet EMA/FDA/ANVISA requirements for organ impairment studies.
Why Astrum Porto
- Hospital-based environment with ICU and emergency support for patient safety.
- 11-hospital network enabling fast recruitment of renal impairment cohorts.
- Inspected by EMA, FDA & ANVISA – ensuring global acceptance of data.
- Proven expertise in complex renal PK/PD designs, including dialysis patients.
- Integrated pathway: from healthy volunteer studies → special populations → registrational evidence.