Healthy Combine Study

NCT03136705 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: STU00090161
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

STUDY SUMMARY Title: EFFECTS OF NICOTINAMIDE AND LANTHANUM CARBONATE ON PHOSPHORUS HOMEOSTASIS Protocol Number:STU00090161 Phase: Phase 1, detailed physiologic study Methodology: double blind, randomized, placebo-controlled, 2x2 factorial Study Duration: 12-18 months (to complete the entire study protocol) Study Center: Single-center Objectives: Define short-term effects of the interventions (lanthanum carbonate and nicotinamide) on indices of phosphate handling Number of Subjects: 80 Diagnosis and Main Inclusion Criteria: Healthy volunteers Study Product(s), Dose,Route, Regimen: Nicotinamide, 750 mg by mouth twice daily, Lanthanum carbonate, Fosrenol, 1000 mg by mouth three times daily with meals Duration of administration: 2 weeks (length of time study participants are enrolled in study) Reference therapy: reference is a placebo Statistical Methodology: Repeated measures analysis using mixed linear models

Conditions

Healthy

Keywords

Phosphorus Homeostasis; FGF23; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Change in Intact FGF23

  Longitudinal change in serum intact FGF23 levels from baseline visit through completion of study.

  Approximately 3 weeks.

Secondary Outcomes (2)

• Change in Plasma Phosphorus Level

  Approximately 3 weeks.

• Change in 24 Hour Urinary Phosphorus Level

  Approximately 3 weeks.

Study Arms (4)

Lanthanum + Nicotinamide

ACTIVE COMPARATOR

Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks

Drug: Nicotinamide; Drug: Lanthanum Carbonate

Lanthanum + Nicotinamide Placebo

ACTIVE COMPARATOR

Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks

Drug: Lanthanum Carbonate; Drug: Nicotinamide Placebo

Lanthanum Placebo + Nicotinamide

ACTIVE COMPARATOR

Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks

Drug: Nicotinamide; Drug: Lanthanum Carbonate Placebo

Lanthanum Placebo + Nicotinamide Placebo

PLACEBO COMPARATOR

Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks

Drug: Lanthanum Carbonate Placebo; Drug: Nicotinamide Placebo

Interventions

Nicotinamide DRUG

Nicotinamide tablet

Lanthanum + Nicotinamide; Lanthanum Placebo + Nicotinamide

Lanthanum Carbonate DRUG

Lanthanum Carbonate tablet

Also known as: Fosrenol

Lanthanum + Nicotinamide; Lanthanum + Nicotinamide Placebo

Lanthanum Carbonate Placebo DRUG

Sugar pill manufactured to look like Lanthanum Carbonate tablet

Also known as: Placebo (for Lanthanum Carbonate 500mg tablet)

Lanthanum Placebo + Nicotinamide; Lanthanum Placebo + Nicotinamide Placebo

Nicotinamide Placebo DRUG

Sugar pill manufactured to look like Nicotinamide tablet

Also known as: Placebo (for Nicotinamide 750mg tablet)

Lanthanum + Nicotinamide Placebo; Lanthanum Placebo + Nicotinamide Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers
• Age ≥ 18 years, at the time of screening
• Normal renal function at screening, as defined by
• eGFR \> 60
• no albuminuria
• normal urinalysis
• normotensive, defined as blood pressure \<140/85mmHg
• no known history of CKD
• Adequate organ and marrow function at screening as defined below:
• HCT ≥ 30%
• platelets ≥ 125,000/mm3
• total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit
• hydroxyvitamin D ≥ 10mg/dL
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

You may not qualify if:

• History of allergic reaction to nicotinamide, niacin (excluding flushing), and/or multivitamin preparations
• Liver disease, defined as known cirrhosis by imaging or physician diagnosis.
• Documented alcohol use \> 14 drinks/week
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or alkaline phosphatase concentrations \> 2 times the upper limit of the local laboratory reference range and/or total bilirubin concentration not within institutional limits.
• Creatine kinase (CK) concentrations \> 2 times the upper limit of the local laboratory reference range at screening
• Major hemorrhagic event within the past six months from screening requiring inpatient admission.
• Blood or platelet transfusion within the past six months from screening
• History of primary hyperparathyroidism
• Current, clinically significant malabsorption
• Anemia (screening HCT \< 30%) at screening
• Plasma albumin \< 2.5 mg/dl at screening
• hydroxyvitamin D \<10mg/dL at screening
• Inability or unwillingness to provide consent
• Current or recent treatment (within the last 14 days from screening) with niacin/nicotinamide \> 100 mg/day
• Current or recent use of MVI containing niacin/nicotinamide \> 100 mg/day

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Center for Translational Metabolism and Health (CTMH), Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Niacinamide; lanthanum carbonate; Tablets

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Doctor
• Organization: Northwestern University Feinberg School of Medicine

tamara.isakova@northwestern.edu

312-503-6921

Study Officials

• Tamara Isakova, MD, MMSc

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Department of Medicine-Nephrology, Director of the Center for Translational Metabolism and Health

Model Details: Double blind, randomized, placebo-controlled, 2x2 factorial

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: May 2, 2017
• Study Start: February 3, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 23, 2024
• Results First Posted: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)