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Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01485900
First received: November 24, 2011
Last updated: August 22, 2012
Last verified: August 2012

November 24, 2011
August 22, 2012
November 2011
August 2012   (final data collection date for primary outcome measure)
Number of patients reporting Adverse Events (AEs) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01485900 on ClinicalTrials.gov Archive Site
  • Clinical safety laboratory measurement including hematology and biochemistry [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • urine and blood renal function markers [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • AUC [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • t1/2z [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 24-hr ambulatory blood pressure [ Time Frame: Day-1, Day 14 and Day 19 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Hemodynamics of Ascending Repeated Oral Doses of SAR407899A in Patients With Moderate Chronic Kidney Disease on Stable Angiotensin Converting Enzyme-inhibitor (ACE-I) Treatment

Primary Objective:

  • To assess the tolerability and safety of repeated oral ascending doses of SAR407899A in patients with moderate chronic kidney disease (CKD) on stable angiotensin converting enzyme-inhibitor (ACE-I)

Secondary Objectives:

  • To assess in patients with moderate CKD the effect of concomitant multiple dose of SAR407899A and ACE-Is on office and 24-hr ambulatory blood pressure and heart rate
  • The effect of repeated multiple doses of SAR407899A on the pharmacodynamic response to ACE-Is (AcSDKP)
  • The pharmacokinetic profile of repeated oral administration of SAR407899A during co-administration of ACE-Is

The total duration for this study will be around 8 weeks.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Kidney Disease
Drug: SAR407899A

Pharmaceutical form:capsule

Route of administration: oral

  • Experimental: Cohort 1
    Dose 1: 20 days 3-step uptitration with doses A, B, and C of SAR407899 vs. placebo
    Intervention: Drug: SAR407899A
  • Experimental: Cohort 2
    Dose 2: 20 days 3-step uptitration with doses B, C and D of SAR407899 vs. placebo
    Intervention: Drug: SAR407899A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Male and female patients aged between 18 and 79
  • Patients with chronic kidney disease (CKD-3)
  • Patients should be on stable ACE-I treatment (same type and regimen) for at least 2 months prior to screening
  • Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 100 kg inclusive if female
  • If female, patients must be permanently sterilized for more than 3 months or postmenopausal
  • Having given written informed consent prior to the study.

Exclusion criteria:

  • Women of child bearing potential.
  • Uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness
  • Active hepatitis, hepatic insufficiency
  • Acute renal failure
  • Patients requiring dialysis during the study
  • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
  • Any history of orthostatic dysregulation (including but not limited to neurocardiogenic syncope, postural orthostatic tachycardia syndrome)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Moldova, Republic of,   Romania
 
NCT01485900
TDR12446, 2011-003793-83, U1111-1123-5699
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP