Phase 2 Study of FG-4592 in Subjects With Anemia and Chronic Kidney Disease Not Requiring Dialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT00761657
First received: September 25, 2008
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The primary objective of the study is to evaluate the safety, tolerability and pharmacodynamic effects of 5 different oral doses of FG-4592 administered two times or three times weekly for up to 4 weeks to subjects with Chronic Kidney Disease not requiring dialysis.


Condition Intervention Phase
Chronic Kidney Disease
Anemia
Drug: FG-4592
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Single-blind, Placebo-controlled, 4-Week Treatment Study of the Safety and Biologic Activity of Escalating Multiple Oral Doses of FG-4592 in Subjects With Chronic Kidney Disease Not Requiring Dialysis

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • Safety and Tolerability of FG-4592 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize Trough concentrations of FG-4592 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamic effects of FG-4592 on anemia [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
FG-4592 1.0 mg/kg
Drug: FG-4592
FG-4592 1.0 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
Experimental: B
FG-4592 1.5 mg/kg
Drug: FG-4592
FG-4592 1.5 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
Experimental: C
FG-4592 2.0 mg/kg
Drug: FG-4592
FG-4592 2.0 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
Experimental: D
FG-4592 2.5 mg/kg
Drug: FG-4592
FG-4592 2.5 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
Experimental: E
FG-4592 3.0 mg/kg
Drug: FG-4592
FG-4592 3.0 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
Placebo Comparator: F
Placebo
Drug: FG-4592
Placebo Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
Experimental: G
FG-4592 0.7 mg/kg
Drug: FG-4592
FG-4592 0.7 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 to 75 years of age.
  2. Chronic Kidney Disease stage 3 or 4 with hemoglobin < 11.0 g/dL
  3. Normal iron studies.
  4. Normal folate and vitamin B12 levels.
  5. Liver function tests within normal limits at screening.
  6. Absence of active or chronic rectal bleeding.
  7. Absence of diagnosis of age-related macular degeneration (AMD), diabetic macular edema or diabetic proliferative retinopathy that is likely to require treatment during the trial.
  8. Female subjects must not be pregnant nor breast-feeding.
  9. Male subjects with partners who can have children must agree to use a medically acceptable method of contraception.

Exclusion Criteria:

  1. Seropositive for HIV.
  2. History of chronic liver disease.
  3. History of polycystic kidney disease (PKD).
  4. Uncontrolled hypertension (diastolic BP >110 mm Hg or systolic BP >170 mm Hg at screening).
  5. New York Heart Association Class III or IV congestive heart failure.
  6. Recent myocardial infarction or acute coronary syndrome.
  7. History of myelodysplastic syndrome.
  8. Any history of malignancy or a known genetic predisposition for developing cancer (e.g., with diagnostic markers suggesting a genetic predisposition of cancer) except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps.
  9. Active inflammatory infection or chronic inflammatory disease
  10. Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study.
  11. Blood clots within 4 weeks.
  12. History of ongoing hemolysis or diagnosis of hemolytic syndrome.
  13. Known history of bone marrow fibrosis.
  14. History of hemosiderosis or hemochromatosis.
  15. Androgen therapy within 12 weeks.
  16. Red blood cell transfusion within 12 weeks.
  17. Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days.
  18. Intravenous iron supplementation within the past 60 days.
  19. Currently taking acetaminophen >2.6 g/day.
  20. History of prior organ transplantation.
  21. Alcohol consumption greater than 3 or more drinks per day within the past year.
  22. Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1.
  23. Positive urine toxicology screen for a substance that has not been prescribed for the subject.

For subjects aged over 75 years but who otherwise meet all other patient selection criteria, subjects will be evaluated on a case-by-case basis and can be included in this study, per discretion of sponsor's physician representative such as medical monitor or clinical leader.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761657

  Show 34 Study Locations
Sponsors and Collaborators
FibroGen
  More Information

No publications provided

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT00761657     History of Changes
Other Study ID Numbers: FGCL-SM4592-017
Study First Received: September 25, 2008
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by FibroGen:
Kidney
Chronic Kidney Disease
CKD
Stage 3 or 4 Chronic Kidney Disease
Renal
Anemia
Oral anemia treatment
Hemoglobin levels
Blood count
Erythropoietin

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 16, 2014