Renal impairment

From mild renal impairment to end stage renal disease

CRS has profound experience in renal impairment trials

CRS has considerable expertise and long-standing experience in conducting early phase clinical trials in the field of nephrology or rather renal impairment. This specifically includes clinical trials with challenging pharmacokinetic (PK) and pharmacodynamic (PD) designs and trials enrolling special populations such as seriously ill subjects suffering from end stage renal disease (ESRD) and patients undergoing dialysis. All in all, CRS ensures highest quality from trial planning to completion and for reliable results.

CRS in Kiel Hepatology
CRS, in particular CRS Kiel, currently runs approximately eight renal impairment clinical trials per year with a duration of four to six months each.

renal impairment clinical trials by CRS

In recent years, clinical trials with dose titration, different drug formulations, different routes of administration, as well as blinded and unblinded designs have been performed on both inpatients and outpatients. All trials have been executed efficiently and effectively with an overall consistent timely recruitment and with highly reliable results.

The successful conduct of renal impairment clinical trials by CRS can be attributed to the advanced level of expertise and long-standing experience of the CRS Kiel team, led by Dr Atef Halabi, a board-certified internist and Managing & Medical Director of CRS Kiel. His team has conducted more than 150 trials in patients with renal impairment since the early 90s.

The CRS database allows easy identification and rapid recruitment of volunteers, patients with renal insufficiency, as well as matched elderly controls. Our recruitment capabilities are supported by a well-established and long-standing collaboration with a network of nephrologists, large nephrology outpatient departments, specialists at the nephrology department of the university hospital in Kiel, and nephrological dialysis centers.

Moreover, CRS has access to hospital beds for dialysis at Kiel’s university hospital.

Additionally, the local medical lab partner of CRS Kiel, LKF – Laboratorium für Klinische Forschung GmbH, which is specialized and accredited for the support of clinical trials, secures a reliable and rapid turnaround of laboratory results, most of which will be supplied within six hours. This facilitates screening and review of inclusion/exclusion criteria, as well as close safety monitoring of trial participants.

Last but not least: CRS is recognized by competent authorities for being among the top recruiters word-wide for patients suffering from renal insufficiency.

CRS offers its services to all players in clinical development and supports big pharma corporations just like small biotech companies.

CRS Kiel

Renal assessment techniques employed at CRS

  • Estimated glomerular filtration rate (eGFR)
  • Renal plasma flow rate
  • Urinary output
  • Urinary electrolyte and creatinine excretion
  • Cystatin C (CysC)
  • Osmolarity
  • Iohexol
  • Pharmacokinetic assessments during the process of dialysis