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 | Completed Phase 1 DMC

• 1 other identifier: AOM08193
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Chronic Kidney Disease

Keywords

Chronic kidney disease; GFR; Inulin; 51Cr-EDTA; ASDKP-NH2; Healthy male 18-35 yrs old, non smokers, non allergic; Or Male/female 18-80 yrs old with chronic Kidney disease

Outcome Measures

Primary Outcomes (1)

• glomerular filtration rate

  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.

  between day 7 and day 21

Secondary Outcomes (1)

• safety

  One month extended to 3 months safety follow up

Study Arms (2)

AcSDKP-NH2 inuline

EXPERIMENTAL

AcSDKP-NH2 inuline, Once intravenous administration of 100 µg or less

Drug: AcSDKP-NH2 inuline

AcSDKP-NH2 Cr-EDTA

EXPERIMENTAL

AcSDKP-NH2 Cr-EDTA, Once intravenous administration of 100 µg or less

Drug: AcSDKP-NH2 Cr-EDTA

Interventions

AcSDKP-NH2 inuline DRUG

Once intravenous administration of 100 µg or less

AcSDKP-NH2 inuline

AcSDKP-NH2 Cr-EDTA DRUG

Once intravenous administration of 100 µg or less

AcSDKP-NH2 Cr-EDTA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase I: 18-35 years male
• Phase I: healthy volunteers
• Phase II: 18-80 years patients (both sex)
• Phase II: with Chronic Kidney Disease

You may not qualify if:

• Phase I: Smokers
• Phase I: Allergic

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Clinical Investigation Center, European George Pompidou Hospital

Paris, 75015, France

Location

Related Publications (1)

• Mesmin C, Cholet S, Blanchard A, Chambon Y, Azizi M, Ezan E. Mass spectrometric quantification of AcSDKP-NH2 in human plasma and urine and comparison with an immunoassay. Rapid Commun Mass Spectrom. 2012 Jan 30;26(2):163-72. doi: 10.1002/rcm.5326.

  PMID: 22173804 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel AZIZI, MD, PhD

  Université Paris-Descartes, Faculté de Médecine; Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Centre d'Investigations Cliniques; INSERM, CIC 9201, F-75015 Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: May 1, 2012
• Study Start: October 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

FR (1)