End Stage Renal DiseasePhase 2NCT00530114
Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia
A Phase 2 study testing AMG 223 in people with End Stage Renal Disease and Chronic Kidney Disease, run by Amgen.
Trial summary
The primary objectives of this study are the following: 1. To demonstrate that AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis 2. To describe a dose response for AMG 223 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Chronic Kidney Disease, Hyperphosphatemic
- What is being tested?
- AMG 223
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Feb 2009
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Maintenance hemodialysis 3 times a week for at least 3 months prior to screening
- Single pool Kt/V at least 1.2 or urea reduction ratio at least 65%
- Serum phosphorus level of 3.5 to 6.5 mg/dL inclusive at screening
- No change(s) in type or dose of non-investigational phosphate binder(s) for at least 1 month prior to screening
- Serum albumin > 3.0 mg/dL at screening
- If applicable, an increase in serum phosphorus of greater than or equal to 1.5 mg/dL, and a serum phophorous level > 5.5 mg/dL and less than or equal to 10 mg/dl during the washout period
- If applicable, stable doses (defined as no change in dose for at least 1 month prior to screening) of Vitamin D replacement, calcimimetic agents, or bedtime calcium supplements
- Willingness to avoid intentional changes in diet such as fasting or dieting
Who cannot join
- Previous intolerance leading to discontinuation of polymer-based phosphate binder therapy
- History of noncompliance with phosphate binder therapy in the opinion of the investigator
- Anticipating or scheduled for a living related-donor kidney transplant, or a prior recipient of a kidney transplant
- Current use of antiarrhythmic or anti-seizure medication
- Active ethanol or drug dependence or abuse, excluding tobacco use
- A screening serum calcium (corrected for albumin) < 8.4 mg/dL
Show all 11Show fewer
- History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders, major gastrointestinal surgery, or gastric/duodenal ulcers within 6 months prior to screening
- Subject is pregnant, breast feeding, or is of child bearing potential and is not using adequate contraceptive precautions
- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s)
- Subject has experienced a myocardial infarction or major surgery (excluding vascular access surgery) within 3 months prior to screening
- Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of localized basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Fixed Dose Study of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia
The primary objectives of this study are the following:
- To demonstrate that AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis
- To describe a dose response for AMG 223
- To evaluate the safety and tolerability of AMG 223
- Being tested
- AMG 223, Placebo
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 223Drug
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
PlaceboDrug
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally Receives: Drug: Placebo |
| AMG 223 | Experimental | 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally Receives: Drug: AMG 223 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis
Measured: TREATMENT PERIOD
Secondary outcomes (2)
To describe a dose response for AMG 223
Measured: TREATMENT PERIOD
To evaluate the safety and tolerability of AMG 223
Measured: ENTIRE STUDY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startMar 2008
- Primary completionNov 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530114
- Sponsor's protocol ID
- 20070664
- Status last verified
- Feb 2016
- First submitted
- 13 Sep 2007
- Last updated
- 14 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Fixed Dose Study of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT00530114
- Acronym / sponsor ID
- 20070664
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 17 Sep 2007 (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 primary objectives of this study are the following:
- To demonstrate that AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis
- To describe a dose response for AMG 223
- To evaluate the safety and tolerability of AMG 223
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
| AMG 223 | Experimental | Drug: AMG 2231.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Maintenance hemodialysis 3 times a week for at least 3 months prior to screening
- Single pool Kt/V at least 1.2 or urea reduction ratio at least 65%
- Serum phosphorus level of 3.5 to 6.5 mg/dL inclusive at screening
- No change(s) in type or dose of non-investigational phosphate binder(s) for at least 1 month prior to screening
- Serum albumin > 3.0 mg/dL at screening
Key exclusion criteria (11 listed)
- Previous intolerance leading to discontinuation of polymer-based phosphate binder therapy
- History of noncompliance with phosphate binder therapy in the opinion of the investigator
- Anticipating or scheduled for a living related-donor kidney transplant, or a prior recipient of a kidney transplant
- Current use of antiarrhythmic or anti-seizure medication
- Active ethanol or drug dependence or abuse, excluding tobacco use
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 |
|---|---|---|
| AMG 2231.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally | Drug | AMG 223 |
| Placebo1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally | Drug | Placebo |
Primary outcome
To demonstrate the AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis
Time frame: TREATMENT PERIOD
2 secondary outcomes
To describe a dose response for AMG 223
Time frame: TREATMENT PERIOD
To evaluate the safety and tolerability of AMG 223
Time frame: ENTIRE STUDY
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 14 Mar 2016.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 223 in people with End Stage Renal Disease and Chronic Kidney Disease, run by Amgen.
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 8 inclusion and 11 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To demonstrate the AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis (time frame: TREATMENT PERIOD). 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 14 Mar 2016.