KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
|ClinicalTrials.gov Identifier: NCT02268994|
Recruitment Status : Completed
First Posted : October 20, 2014
Results First Posted : February 21, 2018
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anemia of Chronic Kidney Disease||Drug: ferric citrate Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: KRX-0502 (ferric citrate)
1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
Drug: ferric citrate
1 g ferric citrate containing approximately 210 mg of ferric iron
Other Name: KRX-0502
Placebo Comparator: Placebo
- 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 [ Time Frame: Week 16 ]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.
- Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline [ Time Frame: Baseline and week 16 ]The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.
- Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline [ Time Frame: Baseline and week 16 ]The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.
- Mean Change in Ferritin at the End of 16 Weeks Minus Baseline [ Time Frame: Baseline and week 16 ]The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.
- Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb) [ Time Frame: Week 16 ]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
- Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline [ Time Frame: Baseline and week 16 ]The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268994
Show 36 Study Locations
|Study Chair:||Geoffrey Block, MD||Denver Nephrology|
|Study Chair:||Glenn Chertow, MD||Division of Nephrology at Stanford University School of Medicine|
|Study Chair:||Steven Fishbane, MD||Kidney Disease and Hypertension at North Shore University Hospital/Long Island Jewish Medical Center|