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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 September 16, 2014