Renal ImpairmentPhase 1NCT04623710
Study of ALXN2050 in Participants With Renal Impairment
A Phase 1 study testing ALXN2050 in people with Renal Impairment and Healthy, run by Alexion Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment, Healthy
- What is being tested?
- ALXN2050
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jul 2021to 21 Mar 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body weight must be at least 50.0 kilograms (kg) and body mass index (BMI) within the range of 18.0 - 40.0 kg/meter squared (m^2) (inclusive) at the time of signing the informed consent.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Must agree to receive prophylactic antibiotics to mitigate the potential risk of meningococcal infection.
- Participants with Impaired Renal Function
- Aside from impaired renal function, sufficiently healthy for study participation based upon medical history, physical examination, neurological examination, laboratory tests, vital signs, and electrocardiograms (ECGs).
- A clinical diagnosis of impaired stable renal function.
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- No clinically significant change in renal status at least 1 month prior to first dose of study intervention and is not currently or has not previously been on hemodialysis or did not have any history of peritoneal dialysis.
- Stable creatinine clearance.
- Must be on a stable medication regimen. Concomitant medications must be approved by Alexion unless presented in the list of common concurrent medications for participants with impaired renal function.
- Matched Healthy Control Participants with Normal Renal Function
- Must match the sex and the race (similar ratio of white and non-white) of participants with impaired renal function, and at screening, age must be within ± 10 years and BMI must be within ± 20% of the matching participants with impaired renal function
- Healthy as determined by medical evaluation, including medical history, physical examination, neurological examination, laboratory tests, vital signs, and ECGs, and who possess a baseline eGFR ≥ 90 mL/min/1.73 m^2, based on MDRD equation at screening.
Who cannot join
- History or presence of seizures, head injury, head trauma, or any other brain disorder.
- History of procedures that could alter absorption or excretion of orally administered drugs.
- History of meningococcal infection or a first-degree relative with a history of meningococcal infection.
- Body temperature ≥38.0°Celcius at screening or check-in or history of febrile illness or other evidence of infection, systemic or otherwise, within 14 days prior to the first dose of study intervention.
- Participants with CH50 results outside the reference ranges at screening, unless approved by Alexion
- Significant blood loss or donation of blood within 3 months prior to the first dose of study intervention, donation of plasma within 30 days prior to the first dose of study intervention, receipt of blood products within 6 months prior to first dose of study intervention, or receipt of a vaccine within 30 days prior to the first dose of study intervention.
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- Current enrollment or past participation within the last 30 days (or 5 half-lives, whichever is longer) prior to the first dose of study intervention in the current clinical study or any other clinical study involving an investigational study intervention or any other type of medical research.
- History or presence of drug or alcohol abuse within 1 year prior to the first dose of study intervention, current tobacco user, or positive results for alcohol and/or drug screen at screening or check-in.
- Pregnant or lactating.
- Does not produce sufficient urine output to permit urine sampling at screening and/or check-in or has a history of urinary incontinence prior to check-in.
- History of kidney transplant or actively on a transplant waiting list prior to check-in.
- Any acute or chronic non-renal condition prior to check-in that would limit the participant's ability to complete or participate in this clinical study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Trial Site
Hialeah, Florida, 33014
Clinical Trial Site
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-Label, Multiple-Dose, Parallel Study to Determine the Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of ALXN2050 in Adult Participants
This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function.
Read the detailed description
The study will initiate (Part 1) with participants with severe impaired renal function (Cohort 1) and their matched healthy control participants (Cohort 4). Following data review, the study may proceed (Part 2) with participants with moderate (Cohort 2) and mild (Cohort 3) impaired renal function if deemed necessary.
- Conditions
- Renal Impairment, Healthy
- Being tested
- ALXN2050
- Keywords
- Factor D Inhibitor, Pharmacokinetics, Pharmacodynamics, Safety, ALXN2050
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN2050Drug
Also called ACH-0145228 (formerly)
ALXN2050 (120 milligrams) will be administered orally twice daily on Days 1 through 3, with an additional dose (120 milligrams) administered orally on the morning of Day 4.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Severe Impaired Renal Function | Experimental | Participants will receive ALXN2050. Receives: Drug: ALXN2050 |
| Cohort 2: Moderate Impaired Renal Function | Experimental | Participants will receive ALXN2050. Receives: Drug: ALXN2050 |
| Cohort 3: Mild Impaired Renal Function | Experimental | Participants will receive ALXN2050. Receives: Drug: ALXN2050 |
| Cohort 4: Healthy Control | Experimental | Participants will receive ALXN2050. Receives: Drug: ALXN2050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under The Concentration-time Curve From Time 0 To The 12-hour Time Point (AUC0-12) Of Plasma ALXN2050 After Steady-state
Measured: Up to 72 hours postdose
Area Under The Concentration-time Curve Calculated To The Last Observable Concentration At Time t (AUCt) Of Plasma ALXN2050 After Steady-state
Measured: Up to 72 hours postdose
Maximum (Peak) Steady-state Plasma Concentration (Cmax,ss) Of Plasma ALXN2050
Measured: Up to 72 hours postdose
Time To Reach Maximum (Peak) Plasma Concentration Following ALXN2050 Administration At Steady-state (Tmax,ss)
Measured: Up to 72 hours postdose
Secondary outcomes (4)
Change From Baseline In Complement Factor D Concentration At 24, 48, And 72 Hours Postdose
Measured: Baseline, 24, 48, and 72 hours postdose
Change From Baseline In Plasma b Fragment Of Complement Factor B Concentration
Measured: Baseline, up to 72 hours postdose
Change From Baseline In Complement Alternative Pathway Activity
Measured: Baseline, up to 72 hours postdose
Number Of Participants Receiving ALXN2050 With Treatment-emergent Adverse Events
Measured: Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start8 Jul 2021
- Primary completion18 Feb 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623710
- Sponsor's protocol ID
- ALXN2050-HV-108
- Status last verified
- Sep 2023
- First submitted
- 5 Nov 2020
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multiple-Dose, Parallel Study to Determine the Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of ALXN2050 in Adult Participants
- ClinicalTrials.gov ID
- NCT04623710
- Acronym / sponsor ID
- ALXN2050-HV-108
- Conditions
- Renal Impairment, Healthy
- Keywords
- Factor D Inhibitor, Pharmacokinetics, Pharmacodynamics, Safety, ALXN2050
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 10 Nov 2020 (actual)
- 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.
This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function.
Detailed description
The study will initiate (Part 1) with participants with severe impaired renal function (Cohort 1) and their matched healthy control participants (Cohort 4). Following data review, the study may proceed (Part 2) with participants with moderate (Cohort 2) and mild (Cohort 3) impaired renal function if deemed necessary.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Severe Impaired Renal Function | Experimental | Drug: ALXN2050Participants will receive ALXN2050. |
| Cohort 2: Moderate Impaired Renal Function | Experimental | Drug: ALXN2050Participants will receive ALXN2050. |
| Cohort 3: Mild Impaired Renal Function | Experimental | Drug: ALXN2050Participants will receive ALXN2050. |
| Cohort 4: Healthy Control | Experimental | Drug: ALXN2050Participants will receive ALXN2050. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Body weight must be at least 50.0 kilograms (kg) and body mass index (BMI) within the range of 18.0 - 40.0 kg/meter squared (m^2) (inclusive) at the time of signing the informed consent.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Must agree to receive prophylactic antibiotics to mitigate the potential risk of meningococcal infection.
- Participants with Impaired Renal Function
- Aside from impaired renal function, sufficiently healthy for study participation based upon medical history, physical examination, neurological examination, laboratory tests, vital signs, and electrocardiograms (ECGs).
Key exclusion criteria (12 listed)
- History or presence of seizures, head injury, head trauma, or any other brain disorder.
- History of procedures that could alter absorption or excretion of orally administered drugs.
- History of meningococcal infection or a first-degree relative with a history of meningococcal infection.
- Body temperature ≥38.0°Celcius at screening or check-in or history of febrile illness or other evidence of infection, systemic or otherwise, within 14 days prior to the first dose of study intervention.
- Participants with CH50 results outside the reference ranges at screening, unless approved by Alexion
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 |
|---|---|---|
| ALXN2050Also: ACH-0145228 (formerly)ALXN2050 (120 milligrams) will be administered orally twice daily on Days 1 through 3, with an additional dose (120 milligrams) administered orally on the morning of Day 4. | Drug | Cohort 1: Severe Impaired Renal Function, Cohort 2: Moderate Impaired Renal Function, Cohort 3: Mild Impaired Renal Function, Cohort 4: Healthy Control |
Primary outcome
Area Under The Concentration-time Curve From Time 0 To The 12-hour Time Point (AUC0-12) Of Plasma ALXN2050 After Steady-state
Time frame: Up to 72 hours postdose
Area Under The Concentration-time Curve Calculated To The Last Observable Concentration At Time t (AUCt) Of Plasma ALXN2050 After Steady-state
Time frame: Up to 72 hours postdose
Maximum (Peak) Steady-state Plasma Concentration (Cmax,ss) Of Plasma ALXN2050
Time frame: Up to 72 hours postdose
Time To Reach Maximum (Peak) Plasma Concentration Following ALXN2050 Administration At Steady-state (Tmax,ss)
Time frame: Up to 72 hours postdose
4 secondary outcomes
Change From Baseline In Complement Factor D Concentration At 24, 48, And 72 Hours Postdose
Time frame: Baseline, 24, 48, and 72 hours postdose
Change From Baseline In Plasma b Fragment Of Complement Factor B Concentration
Time frame: Baseline, up to 72 hours postdose
Change From Baseline In Complement Alternative Pathway Activity
Time frame: Baseline, up to 72 hours postdose
Number Of Participants Receiving ALXN2050 With Treatment-emergent Adverse Events
Time frame: Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration)]
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 29 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ALXN2050 in people with Renal Impairment and Healthy, run by Alexion Pharmaceuticals, Inc. 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 12 inclusion and 12 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 29 Sep 2023. 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?
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 Concentration-time Curve From Time 0 To The 12-hour Time Point (AUC0-12) Of Plasma ALXN2050 After Steady-state (time frame: Up to 72 hours postdose). 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 29 Sep 2023.