KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD

Anemia of Chronic Kidney Disease Clinical Trial

Official title:

A Phase 3 Study of KRX-0502 (Ferric Citrate) for the Treatment of Iron Deficiency Anemia (IDA) in Adult Subjects With Non-Dialysis Dependent (NDD) Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268994
• Other study ID #: KRX-0502-306
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2014
• Last updated: February 22, 2018
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2018
• Source: Keryx Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").

Description:

a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period"). The study will consist of 14 clinic visits over a period of 24 weeks. There will be a screening period of up to 14 days; Approximately 230 subjects will be randomized into the Randomized Period in a 1:1 ratio to receive either KRX-0502 or matching placebo, at baseline

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening

2. Age =18 years

3. CKD with Estimated Glomerular Filtration Rate (eGFR) <60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation (with a limit of up to 20% of the target randomization of 230 subjects with eGFR <15 mL/min)

4. Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements (in the opinion of the investigator)

5. Hgb = 9.0 g/dL and =11.5 g/dL at Screening

6. Serum ferritin =200 ng/mL and Transferrin Saturation (TSAT) =25% at Screening

7. Serum Intact Parathyroid Hormone (iPTH) =600 pg/mL at Screening

8. Must consume a minimum of 2 meals per day

9. Willing and able to give written informed consent

Exclusion Criteria:

1. Serum phosphate <3.5 mg/dL at Screening

2. Liver enzymes (ALT/AST) >X3 times upper limit of normal at Screening

3. Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to Screening

4. Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to Screening

5. Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of Screening

6. IV iron administered within 4 weeks prior to Screening

7. Erythropoiesis-stimulating agent (ESA) administered within 4 weeks prior to Screening

8. Blood transfusion within 4 weeks prior to Screening

9. Receipt of any investigational drug within 4 weeks prior to Screening

10. Cause of anemia other than iron deficiency or chronic kidney disease

11. Malignancy (except non-melanoma skin cancer or disease-free for =2 years after curative therapy)

12. History of hemochromatosis

13. Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the PI)

14. Subjects with known allergic reaction to previous oral iron therapy

15. Previous intolerance to oral ferric citrate

16. Psychiatric disorder that interferes with the subject's ability to comply with the study protocol

17. Planned surgery or hospitalization (anticipated to last >72 hours) during the randomized period of the trial other than dialysis access related surgery.

18. Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject

19. Inability to cooperate with study personnel

Related Conditions & MeSH terms

• Anemia
• Anemia of Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• ferric citrate
1 g ferric citrate containing approximately 210 mg of ferric iron
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Mendez Center for Clinical Research	Alexandria	Virginia
United States	Mountain Kidney & Hypertension Associates	Asheville	North Carolina
United States	Kidney Care Associates, LLC	Augusta	Georgia
United States	Research Management, Inc	Austin	Texas
United States	Research Management, Inc.	Austin	Texas
United States	Renal Associates of Baton Rouge	Baton Rouge	Louisiana
United States	Metrolina Nephrology	Charlotte	North Carolina
United States	Creekside Medical Research	DeLand	Florida
United States	Denver Nephrology	Denver	Colorado
United States	Renaissance Renal Research	Detroit	Michigan
United States	Riverside Clinical Research	Edgewater	Florida
United States	Advanced Renal Care	Evergreen Park	Illinois
United States	Nephrology Associates of Northern VA, Inc.	Fairfax	Virginia
United States	California Renal Research	Glendale	California
United States	Peninsula Kidney Associates	Hampton	Virginia
United States	Clinical Research Consultants	Kansas City	Missouri
United States	Southern California Medical Research Center	La Palma	California
United States	Lincoln Nephrology & Hypertension	Lincoln	Nebraska
United States	Academic Medical Research Institute, Inc	Los Angeles	California
United States	TAD Clinical Research	Lufkin	Texas
United States	Renal Physicians of Georgia, PC	Macon	Georgia
United States	Pacific Renal Research Institute	Meridian	Idaho
United States	Pines Clinical Research, Inc	Pembroke Pines	Florida
United States	AKDHC Medical Research Services, LLC	Phoenix	Arizona
United States	Michigan Kidney Consultants, PC	Pontiac	Michigan
United States	Sierra Nevada Nephrology Asoociates	Reno	Nevada
United States	Apex Research of Riverside	Riverside	California
United States	Capital Nephrology Medical Group	Sacramento	California
United States	Clinical Advancement Center	San Antonio	Texas
United States	Kidney & Hypertension Specialists	San Antonio	Texas
United States	San Antonio Kidney Disease Center	San Antonio	Texas
United States	California Institute of Renal Research	San Diego	California
United States	La Jolla Clinical Research, Inc	San Diego	California
United States	Western New England Renal & Transplant Associates	Springfield	Massachusetts
United States	Southwest Kidney Institute	Tempe	Arizona
United States	Kansas Nephrology Research Institute	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Keryx Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Achieving an Increase in Hemoglobin of =1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period	Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.	Week 16
Secondary	Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline	The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.	Baseline and week 16
Secondary	Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline	The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.	Baseline and week 16
Secondary	Mean Change in Ferritin at the End of 16 Weeks Minus Baseline	The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.	Baseline and week 16
Secondary	Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)	Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period	Week 16
Secondary	Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline	The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.	Baseline and week 16