Impaired Renal FunctionPhase 1NCT01716455
Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function
A Phase 1 study testing SSP-004184 in people with Impaired Renal Function, run by Shire at 2 sites in United States.
Trial summary
Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Renal Function
- What is being tested?
- SSP-004184
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Oct 2012to 10 Mar 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- Age 18-85 years inclusive at the time of consent. The elderly treatment group will be defined by an age over 65 years. It is required that at least 4 of the subjects in the elderly group will be over 75 years old.
- All subjects will be "healthy"
- Normal renal function (in 18-65 year-old subjects), defined as an estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study of >90 mL/min/ 1.73 m2 at the Screening Visit.
- The stability of renal function will be confirmed by 2 determinations of serum creatinine separated by at least 7 days
- Subjects with renal impairment
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- Age 18-85 years inclusive at the time of consent.
- Estimated glomerular filtration rate from the MDRD Study is to be estimated at the Screening Visit and should be as described in FDA guidance.
- Subjects must have no clinically significant abnormalities (except for abnormalities explained by the renal impairment disorder).
- All subjects
- Willingness to comply with any applicable contraceptive requirements of the protocol and is:
- Male, or
- Non pregnant, non lactating female
- Females must be at least 90 days post partum or nulliparous.
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any study related procedures. The date of signing informed consent is defined as the beginning of the Screening Period
- Body mass index between 18.5-40.0 kg/m² inclusive. This inclusion criterion will only be assessed at the Screening Visit.
- Hemoglobin of 9.0 g/dL or greater at the Screening Visit and Day -2.
- No clinically significant deviations from the reference ranges for clinical laboratory tests as evaluated by the investigator. Low-density lipoprotein cholesterol value must be <189 mg/dL and triglycerides value must be <499 mg/dL at the Screening Visit.
- Ability to swallow a dose of investigational product.
Who cannot join
- Healthy subjects
- Subject has a clinically significant history or a disorder detected during the medical interview/physical examination
- Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- History of diabetes mellitus, nephrotic syndrome (defined as plasma albumin <30 g/dL and/or proteinuria >3 g/day), or other metabolic endocrine disease known to be associated with alterations in plasma lipid levels. Uncontrolled hypothyroidism is defined as thyroid stimulating hormone (TSH) 1.5 times greater than the upper limit of normal (ULN).
- Subjects with renal impairment
- Current or recurrent disease, other than impaired renal function that could affect, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
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- Concurrent chronic or acute illness or unstable medical condition (other than those associated with their renal disease) that may deteriorate and thus confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
- A potassium concentration >6.2 mmol/L at the Screening Visit.
- Subjects with a renal transplant.
- History of nephrotic syndrome (defined as plasma albumin <30 g/dL and/or proteinuria >3 g/day), or other metabolic endocrine disease known to be associated with alterations in plasma lipid levels (uncontrolled hypothyroidism defined as TSH 1.5 times greater than the upper reference range value).
- Subjects on peritoneal dialysis.
- Uncontrolled systolic or diastolic blood pressure as defined by the investigator.
- Liver enzymes (ALT, AST, GGT) more than 2 fold above ULN at the Screening Visit or on Day -2.
- Uncontrolled diabetes mellitus as determined by the investigator.
- Congestive Heart Failure classified New York Heart Association (NYHA) Class III or IV.
- Any major illness that would in the opinion of the investigator put study subject at risk or interfere with study conduct.
- All subjects
- Acute illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.
- Known or suspected intolerance or hypersensitivity to the investigational products, closely related compounds, or any of the stated ingredients.
- Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months of the Screening Visit.
- History of alcohol or other substance abuse within the last year.
- A positive screen for alcohol or drugs of abuse at the Screening Visit or on Day -2.
- Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day. One alcohol unit=1 beer (12 oz/355 mL) = 1 wine (5 oz/150 mL) = 1 liquor (1.5 oz/40 mL)
- A positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody screen.
- Current use of any other medication (including over-the-counter, herbal or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption, or disposition of the investigational product(s), or clinical or laboratory assessment. (Current use is defined as use within 14 days of dosing). Subjects must be on a stable dose of allowed medications for 14 days prior to dosing.
- Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch) within 30 days prior to the first dose of investigational product.
- Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches or have a history of caffeine withdrawal headaches. (One caffeine unit is contained in the following items: one 6oz/180mL cup of coffee, two 12 oz/355 mL cans of cola, one 12 oz/355 mL cup of tea, three 1oz/28g chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine).
- Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the first dose of investigational product.
- Use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrollment in another drug or vaccine clinical study.
- Substantial changes in eating habits within 30 days prior to receiving the first dose of investigational product, as assessed by the investigator.
- An inability to follow a standardized diet and meal schedule or inability to fast, as required during the study.
- Prior screen failure, randomization, participation, or enrollment in this study.
- Any known hypersensitivity to iohexol or to iodine per se.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Pharmacology of Miami
Miami, Florida, 33014
Orlando Clinical Research Center (OCRC)
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-label, Single-dose Study of the Pharmacokinetics, Safety, and Tolerability of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function
Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias. The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701) following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly subjects and in adult subjects with mild, moderate, severe, and end stage renal disease (ESRD) degrees of impaired renal function. The results of this study will characterize the pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with various degrees of renal impairment, and these data will be compared to healthy adult and elderly subjects.
- Conditions
- Impaired Renal Function
- Being tested
- SSP-004184
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSP-004184Drug
Also called SPD602, FBS0701
| Study group | Role | What they receive |
|---|---|---|
| SSP-004184 (Mild Renal Impairment) | Experimental | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 Receives: Drug: SSP-004184 |
| SSP-004184 (Moderate Renal Impairment) | Experimental | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 Receives: Drug: SSP-004184 |
| SSP-004184 (Severe Renal Impairment) | Experimental | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 Receives: Drug: SSP-004184 |
| SSP-004184 (End Stage Renal Disease) | Experimental | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 Receives: Drug: SSP-004184 |
| SSP-004184 (Healthy Elderly Subjects) | Experimental | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 Receives: Drug: SSP-004184 |
| SSP-004184 (Matched Healthy Subjects) | Experimental | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1. Healthy subjects matched to renally impaired subjects in arms 1 through 4. (Note: One healthy subject can match more than one renally impaired subject.) Receives: Drug: SSP-004184 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Measured: Over 96 hours post-dose
Maximum Plasma Concentration (Cmax) of SSP-004184
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Measured: Over 96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study start29 Oct 2012
- Primary completion10 Mar 2013
- Study completion10 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Impaired Renal FunctionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716455
- Sponsor's protocol ID
- SPD602-104
- Status last verified
- May 2021
- First submitted
- 25 Oct 2012
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose Study of the Pharmacokinetics, Safety, and Tolerability of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT01716455
- Acronym / sponsor ID
- SPD602-104
- Conditions
- Impaired Renal Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2012 (actual)
- Primary completion
- 10 Mar 2013 (actual)
- Study completion
- 10 Mar 2013 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Posted 19 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias. The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701) following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly subjects and in adult subjects with mild, moderate, severe, and end stage renal disease (ESRD) degrees of impaired renal function. The results of this study will characterize the pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with various degrees of renal impairment, and these data will be compared to healthy adult and elderly subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SSP-004184 (Mild Renal Impairment) | Experimental | Drug: SSP-004184All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 |
| SSP-004184 (Moderate Renal Impairment) | Experimental | Drug: SSP-004184All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 |
| SSP-004184 (Severe Renal Impairment) | Experimental | Drug: SSP-004184All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 |
| SSP-004184 (End Stage Renal Disease) | Experimental | Drug: SSP-004184All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 |
| SSP-004184 (Healthy Elderly Subjects) | Experimental | Drug: SSP-004184All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 |
| SSP-004184 (Matched Healthy Subjects) | Experimental | Drug: SSP-004184All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1. Healthy subjects matched to renally impaired subjects in arms 1 through 4. (Note: One healthy subject can match more than one renally impaired subject.) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Healthy subjects
- Age 18-85 years inclusive at the time of consent. The elderly treatment group will be defined by an age over 65 years. It is required that at least 4 of the subjects in the elderly group will be over 75 years old.
- All subjects will be "healthy"
- Normal renal function (in 18-65 year-old subjects), defined as an estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study of >90 mL/min/ 1.73 m2 at the Screening Visit.
- The stability of renal function will be confirmed by 2 determinations of serum creatinine separated by at least 7 days
Key exclusion criteria (33 listed)
- Healthy subjects
- Subject has a clinically significant history or a disorder detected during the medical interview/physical examination
- Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- History of diabetes mellitus, nephrotic syndrome (defined as plasma albumin <30 g/dL and/or proteinuria >3 g/day), or other metabolic endocrine disease known to be associated with alterations in plasma lipid levels. Uncontrolled hypothyroidism is defined as thyroid stimulating hormone (TSH) 1.5 times greater than the upper limit of normal (ULN).
- Subjects with renal impairment
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 |
|---|---|---|
| SSP-004184Also: SPD602, FBS0701 | Drug | SSP-004184 (End Stage Renal Disease), SSP-004184 (Healthy Elderly Subjects), SSP-004184 (Matched Healthy Subjects), SSP-004184 (Mild Renal Impairment), SSP-004184 (Moderate Renal Impairment), SSP-004184 (Severe Renal Impairment) |
Primary outcome
Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184
Time frame: Over 96 hours post-dose
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Maximum Plasma Concentration (Cmax) of SSP-004184
Time frame: Over 96 hours post-dose
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Study Director study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SSP-004184 in people with Impaired Renal Function, run by Shire at 2 sites in United States.
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 20 inclusion and 33 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 10 Jun 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Plasma Concentration-time Curve (AUC) of SSP-004184 (time frame: Over 96 hours post-dose). The study lists 2 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 10 Jun 2021.