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JNJ-42847922 for Kidney Failure

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI; weight [kilogram {kg}]/height [meter {m}]^2) between 18 and 40 kilograms per meter square (kg/m^2) (inclusive) with a body weight not less than 50 kg
All female participants (regardless of childbearing potential), must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, up to 96 hours post-dose (up to day 5)
Awards & highlights

Study Summary

This trial is testing a new drug to see how well it works in people with different levels of kidney function.

Eligible Conditions
  • Kidney Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, up to 96 hours post-dose (up to day 5)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, up to 96 hours post-dose (up to day 5) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under Plasma Analyte Concentration versus Time Curve from Time 0 to Time of Last Measurable Concentration (AUC [0-Last]) of JNJ-42847922 and its Metabolites A and B
Area Under the Plasma Analyte Concentration versus Time Curve from Time 0 to Infinite Time (AUC[0-Infinity]) of JNJ-42847922 and its Metabolites A and B
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-42847922 and its Metabolites A and B
Secondary outcome measures
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Part 2 (Optional): Cohort 3 (JNJ-42847922)Experimental Treatment1 Intervention
Participants with moderate renal impairment (eGFR 30 to 59 mL/min) will receive single oral dose of JNJ-42847922 on Day 1.
Group II: Part 1: Cohort 2 (JNJ-42847922)Experimental Treatment1 Intervention
Participants with severe renal impairment (eGFR 15 to 29 mL/min) will receive single oral dose of JNJ-42847922 on Day 1.
Group III: Parts 1 and 2: Cohort 1 (JNJ-42847922)Active Control1 Intervention
Healthy participants with normal renal function [estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 90 milliliter (mL)/minute (min)] will receive single oral dose of JNJ-42847922 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-42847922
2016
Completed Phase 2
~670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
974 Previous Clinical Trials
6,384,246 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,881 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has JNJ-42847922 been tested in past clinical studies?

"Currently, 6 clinical trials are in progress for JNJ-42847922 with 2 of them being Phase 3. Knoxville, Tennessee is one hub where studies are conducted; however there exist 413 other sites carrying out research related to this compound."

Answered by AI

Has research of this type ever been conducted before?

"JNJ-42847922 was first studied in 2020, with a Phase 1 trial sponsored by Janssen Research & Development. After successful results were achieved, the medication received its approval and there are currently 6 ongoing studies spanning 28 countries and 133 cities."

Answered by AI

For whom is this trial appropriate?

"Patients that satisfy the age criteria (18-80) and have declining renal function can apply to be part of this 32-person trial."

Answered by AI

Are there any openings to join this medical experiment at present?

"As indicated on clinicaltrials.gov, this medical study is currently seeking participants; its inception was March 31st 2021 and it has recently been updated November 9th 2022."

Answered by AI

Has the FDA sanctioned JNJ-42847922 for medicinal use?

"JNJ-42847922's safety is rated a 1 since this Phase 1 trial has scarce evidence of its efficacy as well as limited data outlining the medication's safety."

Answered by AI

How many participants is this clinical trial seeking to enroll?

"Affirmative, according to clinicaltrials.gov the research is actively enrolling participants. It was first posted on March 31st 2021 and updated as recently as November 9th 2022. This medical study seeks out 32 patients from 2 locations for its experimentations."

Answered by AI

Could minors aged under 20 years partake in this trial?

"This clinical study is open to trial participants aged 18-80. For individuals younger than 18 and older than 65, there are 7 trials and 162 trials respectively available."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Effect of Renal Impairment on JNJ-42847922 in Adult Participants
2021. "A Study to Evaluate the Effect of Renal Impairment on JNJ-42847922 in Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04616677.
~6 spots leftby Apr 2025
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