Anemia in End Stage Renal DiseasePhase 2NCT01596855
Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China
A Phase 2 study testing FG-4592 and Epoetin Alfa in people with Anemia in End Stage Renal Disease, run by Kyntra Bio at 9 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on maintenance hemodialysis and receiving epoetin alfa. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia in End Stage Renal Disease
- What is being tested?
- FG-4592 and Epoetin Alfa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 9 sitesChina
- Study dates
- Sep 2011to Jan 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has voluntarily signed and dated an informed consent form
- Age 18 to 75 years
- End-stage renal disease (ESRD) and receiving maintenance hemodialysis TIW for ≥4 months prior to Day 1
- Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be between 9.0 and 12.0 g/dL (inclusive), and the difference between them must be ≤1.5 g/dL.
- Stable doses of IV or Subcutaneous injection of epoetin alfa, defined as follows:
- Epoetin alfa dose range for 6 weeks prior to Day -7:
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- 3000 to 20,000 IU/week
- Stable doses of epoetin alfa (i.e., the maximum epoetin alfa dose does not exceed 130% of the lowest dose of epoetin alfa taken in this period)
- Complete Blood Count (CBC), Hematology, liver function blood tests within acceptable limits
- Serum folate and vitamin B12 levels above the lower limit of normal (LLN)
- Body weight: 40 to 100 kg (dry weight) inclusive
- Body mass index (BMI): 16 to 38 kg/m2 inclusive
- HD subjects: dialysis vascular access via native arteriovenous fistula or synthetic graft (not via catheter)
Who cannot join
- Anticipated change in hemodialysis prescription or access during the screening or dosing period of the study
- Any clinically significant infection or evidence of an underlying infection such as a white blood cell count (WBC) > ULN during screening on two separate occasions,
- Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); anti-hepatitis C virus antibody (anti-HCV Ab)
- History of chronic liver disease
- New York Heart Association Class III or IV congestive heart failure
- Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
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- Active or chronic gastrointestinal bleeding, or a known coagulation disorder
- Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)
- Hematological disorders, including myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
- History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric
- Active hemolysis or diagnosis of hemolytic syndrome
- Known bone marrow fibrosis
- Uncontrolled or symptomatic secondary hyperparathyroidism (PTH>600ng/L)
- Any prior organ transplantation
- Drug-treated gastroparesis, short-bowel syndrome, or any other gastrointestinal condition that may lead to reduced absorption of study drug
- History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject
- Prior treatment with FG-4592
- Use of traditional Chinese medicines (TCM) during the screening visit to Day 1 or plans to use TCM during the study unless approved in advance by the Medical Monitor
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Peking Union Medical College Hospital
Beijing
Peking University First Hospital
Beijing
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou
Zhejiang University No 1. Hospital
Hangzhou
Chang Zheng Hospital
Shanghai
Renji Hospital
Shanghai
RuiJin Hospital
Shanghai
XinHua Hospital
Shanghai
ShenZhen People's Hospital
Shenzhen
About this study
Official title: A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis (HD)
The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on maintenance hemodialysis and receiving epoetin alfa.
Read the detailed description
Dose ranging study with three consecutive dose escalation cohorts. The study objectives are to demonstrate that FG-4592 is effective in maintaining hemoglobin (Hb) levels when converting from epoetin alfa and to establish optimum starting doses and dose adjustment regimens for Hb maintenance.
- Conditions
- Anemia in End Stage Renal Disease
- Being tested
- FG-4592, Epoetin Alfa
- Keywords
- Anemia, Renal
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG-4592Drug
TIW dosing, capsule
Epoetin AlfaDrug
TIW
| Study group | Role | What they receive |
|---|---|---|
| FG-4592 | Experimental | Active Drug Receives: Drug: FG-4592 |
| Epoetin alfa | Active comparator | Standard of care Receives: Drug: Epoetin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin maintenance using FG-4592 dosing regimen in ESRD subjects. Number of subjects who hemoglobin levels are maintained at no lower than 0.5 g/dL below their mean baseline value during weeks 6 and 7.
Measured: Week 7
Secondary outcomes (2)
Number (%) of subjects whose hemoglobin levels are between 9.0 and 13.0 g/dL at Weeks 3, 4, 5, 6 and 7.
Measured: Week 7
Number (%) of subjects whose hemoglobin levels at Weeks 3, 4, 5, 6 and 7 are greater than or equal to their baseline level.
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia in End Stage Renal DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyntra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital, RenJi Hospital, Chang Zheng Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Peking University First Hospital, First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Zhejiang University, Peking Union Medical College Hospital, Shenzhen People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596855
- Sponsor's protocol ID
- FGCL-4592-048
- Status last verified
- Jan 2013
- First submitted
- 30 Apr 2012
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PubMed 36005278
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis (HD)
- ClinicalTrials.gov ID
- NCT01596855
- Acronym / sponsor ID
- FGCL-4592-048
- Conditions
- Anemia in End Stage Renal Disease
- Keywords
- Anemia, Renal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital, RenJi Hospital, Chang Zheng Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Peking University First Hospital, First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Zhejiang University, Peking Union Medical College Hospital, Shenzhen People's Hospital
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 May 2012 (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 purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on maintenance hemodialysis and receiving epoetin alfa.
Detailed description
Dose ranging study with three consecutive dose escalation cohorts. The study objectives are to demonstrate that FG-4592 is effective in maintaining hemoglobin (Hb) levels when converting from epoetin alfa and to establish optimum starting doses and dose adjustment regimens for Hb maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FG-4592 | Experimental | Drug: FG-4592Active Drug |
| Epoetin alfa | Active comparator | Drug: Epoetin AlfaStandard of care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject has voluntarily signed and dated an informed consent form
- Age 18 to 75 years
- End-stage renal disease (ESRD) and receiving maintenance hemodialysis TIW for ≥4 months prior to Day 1
- Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be between 9.0 and 12.0 g/dL (inclusive), and the difference between them must be ≤1.5 g/dL.
- Stable doses of IV or Subcutaneous injection of epoetin alfa, defined as follows:
Key exclusion criteria (18 listed)
- Anticipated change in hemodialysis prescription or access during the screening or dosing period of the study
- Any clinically significant infection or evidence of an underlying infection such as a white blood cell count (WBC) > ULN during screening on two separate occasions,
- Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); anti-hepatitis C virus antibody (anti-HCV Ab)
- History of chronic liver disease
- New York Heart Association Class III or IV congestive heart failure
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 |
|---|---|---|
| FG-4592TIW dosing, capsule | Drug | FG-4592 |
| Epoetin AlfaTIW | Drug | Epoetin alfa |
Primary outcome
Hemoglobin maintenance using FG-4592 dosing regimen in ESRD subjects. Number of subjects who hemoglobin levels are maintained at no lower than 0.5 g/dL below their mean baseline value during weeks 6 and 7.
Time frame: Week 7
2 secondary outcomes
Number (%) of subjects whose hemoglobin levels are between 9.0 and 13.0 g/dL at Weeks 3, 4, 5, 6 and 7.
Time frame: Week 7
Number (%) of subjects whose hemoglobin levels at Weeks 3, 4, 5, 6 and 7 are greater than or equal to their baseline level.
Time frame: Week 7
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 4 Feb 2013.
- Derived from this study: PubMed 36005278Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FG-4592 and Epoetin Alfa in people with Anemia in End Stage Renal Disease, run by Kyntra Bio at 9 sites in China.
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 13 inclusion and 18 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 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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 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?
Hemoglobin maintenance using FG-4592 dosing regimen in ESRD subjects. Number of subjects who hemoglobin levels are maintained at no lower than 0.5 g/dL below their mean baseline value during weeks 6 and 7. (time frame: Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596855, which also lists 1 linked publication.
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 4 Feb 2013.