Chronic Kidney DiseasePhase 1NCT01485900
Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment
A Phase 1 study testing SAR407899A in people with Chronic Kidney Disease, run by Sanofi at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- SAR407899A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2011to Aug 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
Read the detailed description
The total duration for this study will be around 8 weeks.
- Conditions
- Chronic Kidney Disease
- Being tested
- SAR407899A
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR407899ADrug
Pharmaceutical form:capsule
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose 1: 20 days 3-step uptitration with doses A, B, and C of SAR407899 vs. placebo Receives: Drug: SAR407899A |
| Cohort 2 | Experimental | Dose 2: 20 days 3-step uptitration with doses B, C and D of SAR407899 vs. placebo Receives: Drug: SAR407899A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients reporting Adverse Events (AEs)
Measured: 8 weeks
Secondary outcomes (8)
Clinical safety laboratory measurement including hematology and biochemistry
Measured: 8 weeks
urine and blood renal function markers
Measured: 8 weeks
ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure)
Measured: 8 weeks
AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro)
Measured: 8 weeks
AUC
Measured: 8 weeks
Cmax
Measured: 8 weeks
t1/2z
Measured: 8 weeks
24-hr ambulatory blood pressure
Measured: Day-1, Day 14 and Day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485900
- Sponsor's protocol ID
- TDR12446
- Other IDs
- 2011-003793-83, U1111-1123-5699
- Status last verified
- Aug 2012
- First submitted
- 24 Nov 2011
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01485900
- Acronym / sponsor ID
- TDR12446
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The total duration for this study will be around 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SAR407899ADose 1: 20 days 3-step uptitration with doses A, B, and C of SAR407899 vs. placebo |
| Cohort 2 | Experimental | Drug: SAR407899ADose 2: 20 days 3-step uptitration with doses B, C and D of SAR407899 vs. placebo |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR407899APharmaceutical form:capsule Route of administration: oral | Drug | Cohort 1, Cohort 2 |
Primary outcome
Number of patients reporting Adverse Events (AEs)
Time frame: 8 weeks
8 secondary outcomes
Clinical safety laboratory measurement including hematology and biochemistry
Time frame: 8 weeks
urine and blood renal function markers
Time frame: 8 weeks
ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure)
Time frame: 8 weeks
AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro)
Time frame: 8 weeks
AUC
Time frame: 8 weeks
Cmax
Time frame: 8 weeks
t1/2z
Time frame: 8 weeks
24-hr ambulatory blood pressure
Time frame: Day-1, Day 14 and Day 19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR407899A in people with Chronic Kidney Disease, run by Sanofi at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Moldova, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients reporting Adverse Events (AEs) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2012.