The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE

NCT02258074 Phase 2 COMPLETED Results posted

The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients with Chronic Kidney Disease (CKD) stages 3-4.

Details

Lead sponsor	The Cleveland Clinic
Phase	Phase 2
Status	COMPLETED
Enrolment	205
Start date	2015-03
Completion	2019-09

Conditions

• Chronic Kidney Disease

Interventions

• Nicotinamide
• Lanthanum Carbonate
• Placebo (for Nicotinamide)
• Placebo (for lanthanum carbonate)

Primary outcomes

• FGF23 — Baseline to 12 months
  Change from baseline to 12 months in FGF23 level.
• Serum Phosphate (mg/dl) — Baseline to 12 months
  Change from Baseline to 12 months in serum phosphate level

Countries

United States