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

NCT02258074 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2021-08-02

Study results available
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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.

Conditions

Interventions

DRUG

Nicotinamide

DRUG

Lanthanum Carbonate

DRUG

Placebo (for Nicotinamide)

Sugar pill manufactured to mimic Nicotinamide 750 mg capsule

DRUG

Placebo (for lanthanum carbonate)

Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Michael F. Flessner, MD, PhD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • John W. Kusek, PhD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Jennifer J Gassman, Ph.D. · Data Coordinating Center, Cleveland Clinic

  • Linda F Fried, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-11-30
Completion
2019-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02258074 on ClinicalTrials.gov