Renal Insufficiency, AcutePhase 1NCT02808052

Evaluate Safety and Pharmacokinetics of Minocin (Minocycline) for Injection in Subjects With Renal Insufficiency

A Phase 1 study testing Minocin (minocycline) for Injection in people with Renal Insufficiency, Acute and Renal Insufficiency, Chronic, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is a Phase 1, open-label, single-dose study of the safety, tolerability, and pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal insufficiency. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Renal Insufficiency, Acute, Renal Insufficiency, Chronic, Healthy Subjects
What is being tested?: Minocin (minocycline) for Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteGermany
Study dates: 29 May 2017to 4 Jun 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

A signed informed consent form, the ability to understand the study conduct and tasks that are required for study participation, and a willingness to cooperate with all tasks, tests, and examinations as required by the protocol, whether in the hospital or after discharge, for the duration of the study;
Healthy adult male or female between 18 and 85 years of age (inclusive) at the time of screening;
Subject has a body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 45 kg/m2;
Pulse measured at screening/baseline must be within the ranges ≥ 45 to ≤ 115 beats per minute (bpm, taken after resting in a semi-recumbent position for at least 5 minutes);
Have sufficient peripheral vascular access, based on the Investigator's assessment, for all blood sample collections to take place;
Female subject is surgically sterile, postmenopausal, or if of childbearing potential, agrees to abstinence or to use at least 2 acceptable methods of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier methods, etc.) or male partner sterilization alone, between randomization and for 7 days after the completion of the study;

Show all 16Show fewer

Subjects with Renal Insufficiency:
Assessment of renal insufficiency for assignment to study groups will be based on measurements of estimated glomerular filtration rate calculated by the Modification of Diet in Renal Disease equation at the screening visit to determine eligibility;
Subjects with Normal Renal Function:
Normal volunteers first matched by age (± 10 years), BMI (± 20%), and gender to the mean values of the moderate renal insufficiency group. Once the mild, moderate, and severe renal insufficiency groups are fully enrolled, the mean values of age, BMI, and gender will be calculated for the pooled renal insufficiency groups, and additional healthy subjects may be enrolled to match the pooled means;
Have a creatinine clearance (CrCl) ≥ 90 mL/min calculated using the Cockcroft Gault equation;
Hemodialysis Subjects:
Receiving stable hemodialysis (Kt/V > 1.2) at least 3 times a week for at least 3 months, using an arteriovenous fistula or graft;
Otherwise considered to be clinically stable with respect to underlying renal impairment, as determined by the Investigator, and based upon a medical evaluation that includes a medical history, physical examination, laboratory tests, and electrocardiogram (ECG);
Have clinical laboratory test results that are considered clinically stable in the opinion of the Investigator, especially if the clinical abnormality or laboratory parameter is deemed associated with the subject's underlying renal impairment;
A stable medication regimen is required, defined as not starting new drug(s) or significant changes in dosage(s) within 14 days prior to administration of study drug, or during the conduct of the study. Changes of medications in hemodialysis subjects are subject to dialysis site protocols such that erythropoiesis-stimulating agents, iron, and vitamin D can be changed based on the then current subject status and dialysis unit standard practice and subject safety prior to screening.

Who cannot join

Has any condition, including findings in the medical history or in pre-study assessments, that are capable of altering the distribution, metabolism, or elimination of drugs or that constitute a risk or a contraindication for the participation in the study or completing the study; Subjects in the renal insufficiency groups will have consideration for the degree of renal insufficiency and presence of comorbidities;
Current evidence or history of malignancy, excluding basal cell carcinoma, in the 2 years prior to Day -1 (day before dosing) with no evidence of recurrence;
Blood or plasma donation within past 2 months;
Vigorous exercise from 48 hours prior to Day -1 until the day of discharge from the study;
Surgery within 48 hours prior to randomization or surgery planned during the study period;
Liver function abnormalities at screening (or Day -1) (defined by an elevation in bilirubin, aspartate aminotransferase, or alanine aminotransferase that is 1.5 x upper limit of normal of the normal range for subjects based on age and sex);

Show all 33Show fewer

Females who are pregnant or nursing or who have a positive pregnancy test result;
Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period (i.e., condom with spermicide, where locally available);
Presence of known raised intracranial pressure;
Use of isotretinoin;
History of significant hypersensitivity or allergic reaction to tetracycline antibiotics;
History of seizures (e.g., epilepsy), head injury, or meningitis requiring ongoing anti-seizure medications;
Receipt of any investigational medication or investigational device during the last 30 days prior to randomization;
A corrected QT (Fridericia) > 500 msec or history of prolonged QT syndrome;
Use of products containing alcohol, caffeine, xanthine, or ephedrine within 48 hours before dosing;
Unable or unwilling, in the judgment of the Investigator, to comply with the protocol;
Subjects that have known active hepatitis B or C, or human immunodeficiency virus (HIV) infection or have known immune deficiency disease at screening;
Concurrent use of medications known to affect the elimination of serum creatinine (e.g., trimethoprim/sulfamethoxazole [Bactrim®] or cimetidine [Tagamet®]) and competitors of renal tubular secretion (e.g., probenecid) within 30 days prior to the first dose of study drug or anticipated need for these therapies through the last PK sample;
An employee of the Investigator or study center or sponsor, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center or the Sponsor, or a family member of the employee or the Investigator.
Subjects with Renal Insufficiency:
Have a sitting systolic blood pressure (BP) > 180 mm Hg or < 90 mm Hg or have a sitting diastolic BP > 110 mm Hg or < 50 mm Hg at the screening visit;
Use of any other prescription or nonprescription drugs, vitamins, grapefruit/grapefruit juice, or dietary or herbal supplements within 14 days prior to Day -1 other than those listed below:
Medications required to treat underlying renal disease or medical conditions related to renal disease are permitted;
Oral contraceptives are permitted for birth control;
Doses of concomitant medications (except hormonal contraceptives, hormone replacement therapy for females, and insulin) must be stable for 3 weeks prior to dosing on Day 1. Minor dose changes consistent with treatment practices may be permitted at the discretion of the Sponsor's Medical Monitor;
Acetaminophen (≤ 1 g/day) and low dose acetylsalicylic acid (ASA, e.g., ≤ 325 mg per day) are permitted.
Subjects with Normal Renal Function:
Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis per Investigator discretion;
Have a sitting systolic BP > 150 mm Hg or < 90 mm Hg or have a sitting diastolic BP > 90 mm Hg or < 50 mm Hg at the screening visit;
CrCl < 90 mL/min calculated using the Cockcroft Gault equation;
Use of any prescription or nonprescription drugs, vitamins, grapefruit/grapefruit juice, or dietary or herbal supplements within 14 days prior to Day -1 other than those listed below:
Oral contraceptives are permitted for birth control;
Acetaminophen (≤ 1 g/day) and low dose ASA (i.e., ≤ 325 mg per day) are permitted.

Trial locations and contacts

1 site in 1 country.

Germany1 site

University Hospital Cologne-Clinical Trial Center
Cologne, 50931

Other trials in Germany

About this study

Official title: A Phase I, Open-Label, Single-Dose Trial To Determine The Safety And Pharmacokinetics Of Minocin (Minocycline) For Injection In Subjects With Renal Insufficiency

This is a Phase 1, open-label, single-dose study of the safety, tolerability, and pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal insufficiency.

Read the detailed description

The purpose of this study is to collect safety, tolerability, and pharmacokinetics (PK) data on a single dose of Minocin® (minocycline) for Injection in subjects with renal insufficiency and in subjects receiving hemodialysis therapy. The safety, tolerability, and PK data will support the compound as a potential clinical candidate in Europe and will inform the development of future Phase 2/3 studies.

Conditions: Renal Insufficiency, Acute, Renal Insufficiency, Chronic, Healthy Subjects
Being tested: Minocin (minocycline) for Injection
Keywords: Bacterial infections
Medical subject headings: Acute Kidney Injury, Renal Insufficiency, Chronic, Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Minocin (minocycline) for InjectionDrug
Also called Minocin, minocycline
200mg IV Minocin given over 1 hour

Study groups in NCT02808052
Study group	Role	What they receive
Minocin (minocycline) for Injection	Experimental	Minocin (minocycline) for Injection will be supplied as a sterile lyophilized powder in single-use 10-mL glass vials. Each vial contains 108 mg of minocycline hydrochloride equivalent to 100 mg of minocycline. Each cohort receives a single 200-mg dose of Minocin (minocycline) for Injection except for the hemodialysis therapy/end stage renal disease cohort, which receives two 200-mg doses. Receives: Drug: Minocin (minocycline) for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events
Safety and Tolerability: Subjects with mild, moderate, or severe renal insufficiency with any adverse events, any serious adverse events, any study related adverse events, and any adverse events with a fatal outcome.
Measured: Approximately 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 20174 Jun 2018

First posted21 Jun 2016 (estimated)
Study start29 May 2017
Primary completion4 Jun 2018
Study completion4 Jun 2018

Why it stopped: Sponsor decision due to change in strategy

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal Insufficiency, AcuteStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02808052
Sponsor's protocol ID: MDCO-MIN-16-03
Other IDs: 702
Status last verified: Aug 2019
First submitted: 17 Jun 2016
Last updated: 4 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)

All Renal Insufficiency, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-Label, Single-Dose Trial To Determine The Safety And Pharmacokinetics Of Minocin (Minocycline) For Injection In Subjects With Renal Insufficiency
ClinicalTrials.gov ID: NCT02808052
Acronym / sponsor ID: MDCO-MIN-16-03
Conditions: Renal Insufficiency, Acute, Renal Insufficiency, Chronic, Healthy Subjects
Keywords: Bacterial infections
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision due to change in strategy
Enrolment: 9 participants (actual)
Lead sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)Industry (pharma, biotech, devices)
Collaborators: Universitätsklinikum Köln, Innovative Medicines Initiative
Study start: 29 May 2017 (actual)
Primary completion: 4 Jun 2018 (actual)
Study completion: 4 Jun 2018 (actual)
First posted: 21 Jun 2016 (estimated)
Results: Posted 24 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a Phase 1, open-label, single-dose study of the safety, tolerability, and pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal insufficiency.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Minocin (minocycline) for Injection	Experimental	Drug: Minocin (minocycline) for InjectionMinocin (minocycline) for Injection will be supplied as a sterile lyophilized powder in single-use 10-mL glass vials. Each vial contains 108 mg of minocycline hydrochloride equivalent to 100 mg of minocycline. Each cohort receives a single 200-mg dose of Minocin (minocycline) for Injection except for the hemodialysis therapy/end stage renal disease cohort, which receives two 200-mg doses.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

A signed informed consent form, the ability to understand the study conduct and tasks that are required for study participation, and a willingness to cooperate with all tasks, tests, and examinations as required by the protocol, whether in the hospital or after discharge, for the duration of the study;
Healthy adult male or female between 18 and 85 years of age (inclusive) at the time of screening;
Subject has a body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 45 kg/m2;
Pulse measured at screening/baseline must be within the ranges ≥ 45 to ≤ 115 beats per minute (bpm, taken after resting in a semi-recumbent position for at least 5 minutes);
Have sufficient peripheral vascular access, based on the Investigator's assessment, for all blood sample collections to take place;

Key exclusion criteria (33 listed)

Has any condition, including findings in the medical history or in pre-study assessments, that are capable of altering the distribution, metabolism, or elimination of drugs or that constitute a risk or a contraindication for the participation in the study or completing the study; Subjects in the renal insufficiency groups will have consideration for the degree of renal insufficiency and presence of comorbidities;
Current evidence or history of malignancy, excluding basal cell carcinoma, in the 2 years prior to Day -1 (day before dosing) with no evidence of recurrence;
Blood or plasma donation within past 2 months;
Vigorous exercise from 48 hours prior to Day -1 until the day of discharge from the study;
Surgery within 48 hours prior to randomization or surgery planned during the study period;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Minocin (minocycline) for InjectionAlso: Minocin, minocycline200mg IV Minocin given over 1 hour	Drug	Minocin (minocycline) for Injection

Primary outcome

Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events
Time frame: Approximately 24 weeks
Safety and Tolerability: Subjects with mild, moderate, or severe renal insufficiency with any adverse events, any serious adverse events, any study related adverse events, and any adverse events with a fatal outcome.

Results and safety

Results posted to the registry on 24 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mild Renal Insufficiency	4	4
Moderate Renal Insufficiency	3	3
Severe Renal Insufficiency	2	2

Primary outcome: Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events

Time frame: Approximately 24 weeks. Count of participants. Unit: Participants

Measure	Mild Renal Insufficiency n = 4	Moderate Renal Insufficiency n = 3	Severe Renal Insufficiency n = 2
Number of subjects with any AE	1	2	1
Number of subjects with any SAE	0	0	0
Number of subjects with study related AE	0	1	1
Number subjects with AE leading to fatal outcome	0	0	0

Population analysed: All subjects (9) subjects who received at least one dose of study drug were included in the safety population used for safety analyses.

Adverse events

Time frame: All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mild Renal Insufficiency	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Moderate Renal Insufficiency	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Severe Renal Insufficiency	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Limitations and caveats (from the sponsor): Early Termination of the study lead to a small number of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Renal Insufficiency, Acute

Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oliver Cornely, MD study director

Universitätsklinikum Köln

Volker Burst, MD, PD principal investigator

Universitätsklinikum Köln

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events (time frame: Approximately 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02808052.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.