A Phase 1 interventional study of Tenofovir Exalidex (TXL) in Renal Impairment, sponsored by ContraVir Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by ContraVir Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
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Among 553 studies in Renal Insufficiency with a site in United States — 40 open to participants now, 57 under way, 3 of them phase 3. Renal Insufficiency · United States.
Among the 553 studies in Renal Insufficiency with a site in United States, this one is the 358th largest by enrollment of the 468 interventional ones that give a count, is one of 21 that started in 2017, is one of 232 in phase 1, and was the 359th registered.
1,412 studies on the registry are indexed under Renal Insufficiency; 145 are open to participants now.
Browse Renal Insufficiency studies →40 of the 553 studies in Renal Insufficiency with a site in United States are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States
Ages 18–80 · Healthy volunteers
Sanofi · Sites in United States
Ages 18–75 · Healthy volunteers
Hoffmann-La Roche · Sites in United States
Ages 18–85 · Healthy volunteers
Merck Sharp & Dohme LLC · Sites in United States
Ages 18–80 · Healthy volunteers
Kailera · Sites in United States
Ages 18–85 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 90 Renal Insufficiency studies recruiting now, 47 (52%) set no upper age limit and 18 (20%) stop at 75 or younger; 8 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
553 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 247 · Phase 2 71 · Phase 3 53 · Phase 4 44
First in 1990; this study’s year is marked. 21 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 40 across 1,060 interventional studies indexed under Renal Insufficiency.
Median enrollment 32 across the 468 interventional studies, 182 across the 82 observational. Of the 464 that completed or were terminated, 169 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
334 of 553 have an industry lead sponsor. The 10 most frequent:
ContraVir Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
ContraVir Pharmaceuticals, Inc. has 1 study filed under Renal Insufficiency — fewer than ten, so there is no comparison to draw.
22 of the studies in Renal Insufficiency with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04020055Phase 3Amicus TherapeuticsA Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease | 2026-12-31 |
| NCT07341516Paris Translational Research Center for Organ TransplantationWorldwide Assessment of Deceased Donor Kidney Utilization | 2026-11 |
| NCT04605679Loma Linda UniversityHepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients | 2026-12 |
| NCT07857837ShionogiStudy of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls | 2026-12-04 |
| NCT03099434Johns Hopkins UniversityExpanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media | 2026-12-07 |
Add all 22 to your calendar (.ics) → With an account.
Among the 553 studies in Renal Insufficiency with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex
This is a Phase 1 study to investigate the effects of Renal Impairment (mild, moderate and severe) on the pharmacokinetics of Tenofovir Exalidex
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)
Severe Renal Impairment subjects Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)
Also known as: lipid conjugate TFV
Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers
Measuring Cmax : the peak plasma concentration
Time frame: up to six days post dose
Evaluation of the adverse events for TXL in RI subjects
review of Adverse events
Time frame: up to six days post dose
Evaluation of safety labs for TXL in RI subjects
review of safety labs
Time frame: up to six days post dose
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Jan 2018, 3 months.
Of 212 industry-sponsored phase 1 interventional studies under Renal Insufficiency, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's 3 months is below that.
Counting every sponsor, half of 230 studies reached it within 8 months; a quarter within 5 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tenofovir exalidex
ContraVir Pharmaceuticals, Inc.