CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 205 enrolled
Drug / intervention
Nicotinamide +3 moredrug
Likely dose
Placebo (for Nicotinamide) 750 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02258074
NCT02258074Phase 2Completed
CompareCT.gov

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

The Cleveland Clinic·interventional·Posted Oct 7, 2014·Updated Aug 2, 2021

In Brief

A Phase 2 clinical trial evaluating Nicotinamide, Lanthanum Carbonate, and 2 other interventions for Chronic Kidney Disease. Completed, enrolled 205 participants across 7 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 7, 2014
Enrollment StartMar 1, 2015
Primary CompletionNov 1, 2018
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.7 years ago

Interventions

Nicotinamidedrug

Lanthanum Carbonatedrug

Placebo (for Nicotinamide)drug

Sugar pill manufactured to mimic Nicotinamide 750 mg capsule

Placebo (for lanthanum carbonate)drug

Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule