Renal Failure, ChronicPhase 1CRLX030A2102NCT01875523
PK of Serelaxin in Severe Renal Impairment and ESRD
A Phase 1 study testing Serelaxin in people with Renal Failure, Chronic and End-Stage Renal Disease, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Failure, Chronic, End-Stage Renal Disease
- What is being tested?
- Serelaxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Dec 2013
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects
- at least 50 years; body mass index (BMI) within the range of 18 - 35 kg/m2.
- Patients with severe renal impairment / ESRD
- Severe renal impairment (clinically significantly abnormal creatinine and creatinine clearance (15mL/min/1.73m2≤eGFR<30mL/min/1.73m2) or ESRD on hemodialysis.
- Sitting vital signs should be within the following ranges:
- oral body temperature between 35.0-37.5 °C
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- systolic blood pressure, 110 to 170 mm Hg
- diastolic blood pressure, 60 to 105 mm Hg
- pulse rate, 45 - 100 bpm
- Healthy subjects
- eGFR > 90mL/min/1.73m2;
- matching in race, age (±10 years), gender, BMI (±15%) to a subject with renal impairment
- Subject must be in good health.
- Sitting vital signs should be within the following ranges:
- oral body temperature between 35.0-37.5 °C
- systolic blood pressure, 100 to 150 mm Hg
- diastolic blood pressure, 60 to 95 mm Hg
- pulse rate, 50 to 100 bpm
Who cannot join
- All subjects
- History of clinically significant ECG abnormalities at Screening or Baseline.
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless they are using highly effective methods of contraception during dosing of study treatment.
- Sexually active males (incl. vasectomized men) must use a condom during intercourse while taking drug and for 2 weeks after stopping study medication.
- Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
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- Patients with severe renal impairment / ESRD:
- Presence of any non-controlled and clinically significant disease, surgical or medical condition that could affect the study outcome or that would place the patient at undue risk as judged by the investigator.
- Hemoglobin levels below 9.0 g/dL at screening and baseline, other laboratory parameters at screening and baseline outside acceptable limits .
- Treatment with any cytostatic drug or autonomic alpha blocker.
- Healthy subjects:
- Use of any prescription drugs (other than hormonal contraception, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
- History or presence of any disease, surgical or medical condition of any major system organ class considered clinically significant by the investigator.
- Laboratory parameter at screening and baseline outside of normal limits. For small deviations which could be attributed to the characteristics of the subjects (e.g. age) it will be to the discretion of the investigator to consider them as exclusive or not.
- A positive Hepatitis B surface antigen or Hepatitis C test result.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of Serelaxin in Patients With Severe Renal Impairment or End-Stage Renal Disease on Hemodialysis Compared to Matched Healthy Control Subjects
The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers.
- Conditions
- Renal Failure, Chronic, End-Stage Renal Disease
- Being tested
- Serelaxin
- Keywords
- Renal disease, renal impairment, End stage renal disease, Healthy volunteer, Pharmacokinetics
- Medical subject headings
- Kidney Failure, Chronic, Kidney Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerelaxinDrug
Also called RLX030
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Treatment with serelaxin | Experimental | Patients with severe renal impairment will receive a single 4 hour i.v. infusion of serelaxin Receives: Drug: Serelaxin |
| Group 2 Treatment with serelaxin | Experimental | Patients with end stage renal disease will receive a single 4 hour i.v. infusion of serelaxin and dialysis will be done on the day of treatment Receives: Drug: Serelaxin |
| Group 3 Treatment with serelaxin | Experimental | Patients with end stage renal disease will receive a single 4 hour i.v. infusion of serelaxin and treatment and PK will be done in dialysis-free interval Receives: Drug: Serelaxin |
| Group 4 Treatment with serelaxin | Experimental | Healthy volunteers will receive a single 4 hour i.v. infusion of serelaxin and dialysis will be done on the day of treatment Receives: Drug: Serelaxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Measured: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
The area under the serum concentration-time curve from time zero to 28 hours after administration (AUC 0-28hr)
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Measured: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
The area under the serum concentration-time curve from time zero to infinity (AUCinf)
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Measured: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
The observed maximum serum concentration following drug administration (Cmax)
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Measured: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
Secondary outcomes (2)
Percentage of patients with reported adverse events, serious adverse events and death.
Measured: From Day -21 to Day 15
Percentage of patients developing anti-RLX030 antibodies
Measured: Day 1 (pre-treatment) and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875523
- Sponsor's protocol ID
- CRLX030A2102
- Other IDs
- 2013-001875-18
- Acronym
- CRLX030A2102
- Status last verified
- Apr 2014
- First submitted
- 7 Jun 2013
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of Serelaxin in Patients With Severe Renal Impairment or End-Stage Renal Disease on Hemodialysis Compared to Matched Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT01875523
- Acronym / sponsor ID
- CRLX030A2102 / CRLX030A2102
- Conditions
- Renal Failure, Chronic, End-Stage Renal Disease
- Keywords
- Renal disease, renal impairment, End stage renal disease, Healthy volunteer, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Jun 2013 (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.
The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 Treatment with serelaxin | Experimental | Drug: SerelaxinPatients with severe renal impairment will receive a single 4 hour i.v. infusion of serelaxin |
| Group 2 Treatment with serelaxin | Experimental | Drug: SerelaxinPatients with end stage renal disease will receive a single 4 hour i.v. infusion of serelaxin and dialysis will be done on the day of treatment |
| Group 3 Treatment with serelaxin | Experimental | Drug: SerelaxinPatients with end stage renal disease will receive a single 4 hour i.v. infusion of serelaxin and treatment and PK will be done in dialysis-free interval |
| Group 4 Treatment with serelaxin | Experimental | Drug: SerelaxinHealthy volunteers will receive a single 4 hour i.v. infusion of serelaxin and dialysis will be done on the day of treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- All subjects
- at least 50 years; body mass index (BMI) within the range of 18 - 35 kg/m2.
- Patients with severe renal impairment / ESRD
- Severe renal impairment (clinically significantly abnormal creatinine and creatinine clearance (15mL/min/1.73m2≤eGFR<30mL/min/1.73m2) or ESRD on hemodialysis.
- Sitting vital signs should be within the following ranges:
Key exclusion criteria (15 listed)
- All subjects
- History of clinically significant ECG abnormalities at Screening or Baseline.
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless they are using highly effective methods of contraception during dosing of study treatment.
- Sexually active males (incl. vasectomized men) must use a condom during intercourse while taking drug and for 2 weeks after stopping study medication.
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 |
|---|---|---|
| SerelaxinAlso: RLX030 | Drug | Group 1 Treatment with serelaxin, Group 2 Treatment with serelaxin, Group 3 Treatment with serelaxin, Group 4 Treatment with serelaxin |
Primary outcome
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
The area under the serum concentration-time curve from time zero to 28 hours after administration (AUC 0-28hr)
Time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
The area under the serum concentration-time curve from time zero to infinity (AUCinf)
Time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
The observed maximum serum concentration following drug administration (Cmax)
Time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
2 secondary outcomes
Percentage of patients with reported adverse events, serious adverse events and death.
Time frame: From Day -21 to Day 15
Percentage of patients developing anti-RLX030 antibodies
Time frame: Day 1 (pre-treatment) and Day 15
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 21 Dec 2020.
- Results for CRLX030A2102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Serelaxin in people with Renal Failure, Chronic and End-Stage Renal Disease, run by Novartis Pharmaceuticals at 1 site in Germany.
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 18 inclusion and 15 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) (time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15). The study lists 4 primary outcomes in all. 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 21 Dec 2020.