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Clinical Trial Details

Trial ID: L0804
Source ID: NCT03106298
Associated Drug: Iron Sucrose
Title: Iron Deficiency and FGF23 Regulation in CKD and HF
Acronym: INDIGO
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases|Chronic Heart Failure|Iron Deficiency Anemia
Interventions: DRUG: Iron Sucrose
Outcome Measures: Primary: Change in c-terminal FGF23 measurements, longitudinal change in plasma c-terminal FGF23 (RU/ml) over 6 weeks and 3 months, Weekly x 6 weeks, 1 longitudinal measurement at 3 months|Change in Intact FGF23 measurements, longitudinal change in plasma intact FGF23 (pg/ml) over 6 weeks and 3 months, Weekly x 6 weeks, 1 longitudinal measurement at 3 months | Secondary: Change in Parathyroid Hormone, longitudinal change in Serum Parathyroid Hormone (pg/ml) over 6 weeks and 3 months, Weekly x 6 weeks, 1 longitudinal measurement at 3 months|Change in Phosphate (mg/dl), longitudinal change in Plasma Phosphate (mg/dl) over 6 weeks and 3 months, Weekly x 6 weeks, 1 longitudinal measurement at 3 months|Change in Serum creatinine, longitudinal change in Serum creatinine (mg/dl) over 6 weeks and 3 months, Weekly x 6 weeks, 1 longitudinal measurement at 3 months|Change in 1,25 dihydroxyvitamin D, longitudinal change in 1,25 dihydroxyvitamin D (pg/ml) over 6 weeks and 3 months, Weekly x 6 weeks, 1 longitudinal measurement at 3 months|Change in C-reactive protein, longitudinal change in C-reactive protein (mg/L) over 6 weeks and 3 months, Weekly x 6 weeks, 1 longitudinal measurement at 3 months|Change in Ferritin Measurement, longitudinal change in serum ferritin (ng/ml) over 6 weeks and 3 months, Weekly x 6 weeks, 1 longitudinal measurement at 3 months|Change in Iron Measurement, longitudinal change in Serum iron (ug/dl) over 6 weeks and 3 months, Weekly x 6 weeks, 1 longitudinal measurement at 3 months|Change in Transferrin Saturation, longitudinal change in Transferrin Saturation (%) over 6 weeks and 3 months, Weekly x 6 weeks, 1 longitudinal measurement at 3 months|Change in Hemoglobin Measurement, longitudinal change in Serum hemoglobin (g/dl) over 6 weeks and 3 months, Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Sponsor/Collaborators: Sponsor: Northwestern University | Collaborators: National Kidney Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 77
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2015-12-18
Completion Date: 2018-08-01
Results First Posted:
Last Update Posted: 2019-03-20
Locations: Northwestern University, Chicago, Illinois, 60607, United States
URL: https://clinicaltrials.gov/show/NCT03106298