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Methylxanthine

Theophylline for Kidney Failure (HONORR Trial)

Phase 2
Waitlist Available
Led By Sagar U Nigwekar, MD, MMSc
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and every 2 weeks for 6 weeks
Awards & highlights

HONORR Trial Summary

This trial is testing whether a drug can improve a person's sense of smell and help them eat better if they are on dialysis.

Eligible Conditions
  • Kidney Failure
  • Olfactory Disorders

HONORR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and every 2 weeks for 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 2 weeks for 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Smell Identification Test Score at 6 Weeks
Change From Baseline in Smell Threshold Test Score at 6 Weeks
Secondary outcome measures
Change From Baseline in Plasma Theophylline Level at 6 Weeks

Side effects data

From 2018 Phase 4 trial • 1670 Patients • NCT02261727
32%
COPD Exacerbation - not hospitalised
16%
COPD Exacerbation - Hospitalised
7%
Upper Respiratory Tract Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Low-dose Theophylline Arm
Theophylline and Prednisone Arm

HONORR Trial Design

1Treatment groups
Experimental Treatment
Group I: Nasal theophyllineExperimental Treatment1 Intervention
20 μg intranasal theophylline (theophylline methylpropyl paraben in a 0.4-mL saline solution) once daily (in the morning) into each naris for a total of 6 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Theophylline
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,934 Previous Clinical Trials
13,198,574 Total Patients Enrolled
7 Trials studying Kidney Failure
857 Patients Enrolled for Kidney Failure
Sagar U Nigwekar, MD, MMScPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
300 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Helping Olfaction and Nutrition On Renal Replacement
Sagar U. Nigwekar, MD, MMSc 2015. "Helping Olfaction and Nutrition On Renal Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02479451.
~1 spots leftby Apr 2025
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