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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01485900
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: SAR407899A Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of patients reporting Adverse Events (AEs) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Clinical safety laboratory measurement including hematology and biochemistry [ Time Frame: 8 weeks ]
  2. urine and blood renal function markers [ Time Frame: 8 weeks ]
  3. ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure) [ Time Frame: 8 weeks ]
  4. AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro) [ Time Frame: 8 weeks ]
  5. AUC [ Time Frame: 8 weeks ]
  6. Cmax [ Time Frame: 8 weeks ]
  7. t1/2z [ Time Frame: 8 weeks ]
  8. 24-hr ambulatory blood pressure [ Time Frame: Day-1, Day 14 and Day 19 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01485900

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

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Responsible Party: Sanofi Identifier: NCT01485900     History of Changes
Other Study ID Numbers: TDR12446
2011-003793-83 ( EudraCT Number )
U1111-1123-5699 ( Other Identifier: UTN )
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

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