Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2)

NCT01588756 Phase 1/Phase 2 COMPLETED

The purpose of the study is to validate a new reference marker for evaluation of renal function (glomerular filtration rate).

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	100
Start date	2010-10
Completion	2015-05

Conditions

• Healthy
• Chronic Kidney Disease

Interventions

• AcSDKP-NH2 inuline
• AcSDKP-NH2 Cr-EDTA

Primary outcomes

• glomerular filtration rate — between day 7 and day 21
  NAcSDKP clearance for GFR measurement is compared to inuline and 51Cr-EDTA clearance in two phase I studies in 50 healthy subjects. GFR is first assessed at equilibrium by measuring urinary clearances of inuline and NAcSDKP continuously co-infused after a loading dose; and second by plasma clearances of 51Cr-EDTA and NAcSDKP after a single IV bolus. Optimal conditions for using NAcSDKP as a marker for GFR and the tolerability of the peptide are assessed during these studies. Then, a phase IIa study will be performed to compare the 2 methods in 45 patients with various degrees of renal failure.

Countries

France