Clinical Trial Details
| Trial ID: | L0346 |
| Source ID: | NCT02258074 |
| Associated Drug: | Nicotinamide |
| Title: | The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE |
| Acronym: | COMBINE |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02258074/results |
| Conditions: | Chronic Kidney Disease |
| Interventions: | DRUG: Nicotinamide|DRUG: Lanthanum Carbonate|DRUG: Placebo (for Nicotinamide)|DRUG: Placebo (for lanthanum carbonate) |
| Outcome Measures: | Primary: FGF23, Change from baseline to 12 months in FGF23 level., Baseline to 12 months|Serum Phosphate (mg/dl), Change from Baseline to 12 months in serum phosphate level, Baseline to 12 months | |
| Sponsor/Collaborators: | Sponsor: The Cleveland Clinic | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 205 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER |
| Start Date: | 2015-03 |
| Completion Date: | 2019-09 |
| Results First Posted: | 2021-07-30 |
| Last Update Posted: | 2021-08-02 |
| Locations: | University of California at San Diego, San Diego, California, 92161, United States|Denver Nephrology Research, Denver, Colorado, 80230, United States|George Washington University, Washington, District of Columbia, 20037, United States|NorthShore University Health System, Chicago, Illinois, 60201, United States|Northwestern University, Chicago, Illinois, 60611, United States|University of Utah, Salt Lake City, Utah, 84112, United States|Utah VA, Salt Lake City, Utah, 84112, United States |
| URL: | https://clinicaltrials.gov/show/NCT02258074 |
