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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
History of Changes
  Purpose

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

Condition Intervention Phase
Chronic Kidney Disease
 Drug: SAR407899A
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients reporting Adverse Events (AEs) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dose 1: 20 days 3-step uptitration with doses A, B, and C of SAR407899 vs. placebo
 Drug: SAR407899A

Pharmaceutical form:capsule

Route of administration: oral
Experimental: Cohort 2
Dose 2: 20 days 3-step uptitration with doses B, C and D of SAR407899 vs. placebo
 Drug: SAR407899A

Pharmaceutical form:capsule

Route of administration: oral

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485900

Locations
Moldova, Republic of
Investigational Site Number 498002
Chisinau, Moldova, Republic of, 2025
Romania
Investigational Site Number 642001
Bucuresti, Romania
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01485900     History of Changes
Other Study ID Numbers: TDR12446, 2011-003793-83, U1111-1123-5699
Study First Received: November 24, 2011
Last Updated: August 22, 2012
Health Authority: Romania: Ethics Committee

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
 Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013