A Phase 2 interventional study of Tesevatinib and Placebo in Autosomal Dominant Polycystic Kidney and ADPKD, sponsored by Kadmon, a Sanofi Company. Completed at 19 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Kadmon, a Sanofi Company (part of Sanofi) · Phase 2, Interventional, and Treatment
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Among 85 studies in Polycystic Kidney, Autosomal Dominant with a site in United States — 14 open to participants now, 25 under way, 1 of them phase 3. Polycystic Kidney, Autosomal Dominant · United States.
Among the 85 studies in Polycystic Kidney, Autosomal Dominant with a site in United States, this one is the 23rd largest by enrollment of the 63 interventional ones that give a count, is one of 6 that started in 2017, is one of 18 in phase 2, and was the 38th registered.
185 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 42 are open to participants now.
Browse Polycystic Kidney, Autosomal Dominant studies →14 of the 85 studies in Polycystic Kidney, Autosomal Dominant with a site in United States are open now. Recruiting first, the newest first:
Vertex Pharmaceuticals Incorporated · Sites in United States
Ages 19–55 · Men only · Healthy volunteers
Kenneth Hallows · Sites in United States
Ages 18–60
Mayo Clinic · Sites in United States
Ages 18–70
Richard Fatica · Sites in United States
Ages 18+
AstraZeneca · Sites in United States, China, United Kingdom
Ages 18–65
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 30 Polycystic Kidney, Autosomal Dominant studies recruiting now, 8 (27%) set no upper age limit and 19 (63%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
85 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 12 · Phase 2 25 · Phase 3 18 · Phase 4 2
First in 1998; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 80 is above the median of 51 across 138 interventional studies indexed under Polycystic Kidney, Autosomal Dominant.
Median enrollment 48 across the 63 interventional studies, 90 across the 22 observational. Of the 59 that completed or were terminated, 34 (58%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 85 have an industry lead sponsor. The 10 most frequent:
This study is registered under Kadmon, a Sanofi Company, one of the names counted as Sanofi. Under that name alone:
Kadmon, a Sanofi Company is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Sanofi has 5 studies filed under Polycystic Kidney, Autosomal Dominant — fewer than ten, so there is no comparison to draw.
16 of the studies in Polycystic Kidney, Autosomal Dominant with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05193981Mayo ClinicA Study to Evaluate Homocysteine Metabolism and Endothelial Function in ADPKD | 2026-12 |
| NCT05288998Mayo ClinicIntrarenal Microvasculature in ADPKD | 2026-12 |
| NCT06786260Loma Linda UniversityDi-PKD: A Pilot Trial of Dietary Intervention in Patients With Autosomal Dominant Polycystic Kidney Disease | 2026-12 |
| NCT04344769Mayo ClinicCharacterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | 2026-12 |
| NCT04630613Mayo ClinicNOX4 and Related Biomarkers in ADPKD | 2026-12 |
Add all 16 to your calendar (.ics) → With an account.
Among the 85 studies in Polycystic Kidney, Autosomal Dominant with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of the study was to compare and evaluate safety and efficacy of tesevatinib 50 milligrams (mg) versus placebo in participants with autosomal dominant polycystic kidney disease (ADPKD).
Safety and efficacy of 50 mg tesevatinib in comparison to placebo in participants with ADPKD was assessed.
The primary purpose of this study was focused on evaluating the change from Baseline in height-adjusted total kidney volume (htTKV) as measured by magnetic resonance imaging (MRI) at Months 12, 18, and 24, and 30 days post-dose in participants with ADPKD treated with tesevatinib or placebo.
If eligible for the study participation, participants were randomly assigned to either investigational treatment group or placebo group. Treatment group received 50 mg tesevatinib once daily for 24 months and control group received the placebo once daily for 24 months.
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.
greater than (>) lower limit of normal (LLN); > 9 grams per deciliter; Total \<= 1.5 milligrams per deciliter; less than (\<) 2.5* (ULN); Alanine aminotransferase \< 2.5*ULN; /partial thromboplastin time \<=1.5*ULN; Serum potassium levels within normal limits; Serum magnesium levels within normal limits; Albumin >= LLN; Amylase \<=1.5*ULN; Lipase \<=1.5*ULN; Prothrombin time and partial thromboplastin time \<=1.5*ULN; International normalized ratio (INR) \<=1.5, except those participants taking warfarin who must have INR \<=3.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received tesevatinib 50 mg tablet orally once daily (QD) for up to 25.3 months.
Drug: Tesevatinib
Participants received placebo matched to tesevatinib tablet orally QD for up to 25.3 months.
Drug: Placebo
Pharmaceutical form: Tablet; Route of administration: orally
Also known as: KD019
Pharmaceutical form: Tablet (identical to tesevatinib); Route of administration: orally
Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12
htTKV was calculated using total kidney volume (in milliliters) obtained from magnetic resonance imaging (MRI) divided by height (in meters). Least square (LS) mean and standard error (SE) were estimated by using analysis of covariance (ANCOVA) model. Change from Baseline in htTKV at Month 12 was reported in this outcome measure.
Time frame: Baseline (Day 1), Month 12
Change From Baseline in Height Adjusted Total Kidney Volume at Month 18
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 18 was reported in this outcome measure.
Time frame: Baseline (Day 1), Month 18
Change From Baseline in Height Adjusted Total Kidney Volume at Month 24
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 24 was reported in this outcome measure.
Time frame: Baseline (Day 1), Month 24
Change From Baseline in Height Adjusted Total Kidney Volume at End of Study
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at end of study (i.e., up to 26 months) was reported in this outcome measure.
Time frame: Baseline (Day 1), End of study (anytime up to 26 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with the treatment. TEAEs were AEs that developed or worsened or became serious from the first dose (Day 1) of the study drug until end of study.
Time frame: From Baseline (Day 1) up to 30 days post last dose of study drug (i.e., up to 26 months)
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 18, 24 and End of Study
eGFR is a test for renal function. eGFR was calculated by using the 4-variable modification of diet in renal disease (MDRD-4) formula reported as milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2). LS mean and SE were estimated using ANCOVA model.
Time frame: Baseline (Day 1), Months 12, 18, 24 and at end of study (i.e., anytime up to 26 months)
The study was conducted at 20 active sites in the United States. A total of 191 participants were screened between 12 October 2017 and 29 January 2020, of which 80 participants were enrolled.
| Milestone | Tesevatinib | Placebo |
|---|---|---|
| Started | 40 | 40 |
| Treated | 38 | 40 |
| Completed | 25 | 29 |
| Not completed | 15 | 11 |
| Withdrew: Adverse event | 3 | 1 |
| Withdrew: Withdrawal by subject | 6 | 6 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Termination of the study by sponsor | 1 | 1 |
| Withdrew: Participant moved | 0 | 1 |
| Withdrew: Investigator's decision | 3 | 0 |
| Withdrew: Other than above specified | 0 | 1 |
htTKV was calculated using total kidney volume (in milliliters) obtained from magnetic resonance imaging (MRI) divided by height (in meters). Least square (LS) mean and standard error (SE) were estimated by using analysis of covariance (ANCOVA) model. Change from Baseline in htTKV at Month 12 was reported in this outcome measure.
| milliliters per meter | Tesevatinib | Placebo |
|---|---|---|
| Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12 | 0.0236 ± 0.0059 | 0.0288 ± 0.0057 |
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 18 was reported in this outcome measure.
| milliliters per meter | Tesevatinib | Placebo |
|---|---|---|
| Change From Baseline in Height Adjusted Total Kidney Volume at Month 18 | 0.0383 ± 0.0081 | 0.0425 ± 0.0075 |
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 24 was reported in this outcome measure.
| milliliters per meter | Tesevatinib | Placebo |
|---|---|---|
| Change From Baseline in Height Adjusted Total Kidney Volume at Month 24 | 0.0485 ± 0.0103 | 0.0607 ± 0.0095 |
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at end of study (i.e., up to 26 months) was reported in this outcome measure.
| milliliters per meter | Tesevatinib | Placebo |
|---|---|---|
| Change From Baseline in Height Adjusted Total Kidney Volume at End of Study | 0.0604 ± 0.0090 | 0.0589 ± 0.0094 |
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with the treatment. TEAEs were AEs that developed or worsened or became serious from the first dose (Day 1) of the study drug until end of study.
| Participants | Tesevatinib | Placebo |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 37 | 40 |
eGFR is a test for renal function. eGFR was calculated by using the 4-variable modification of diet in renal disease (MDRD-4) formula reported as milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2). LS mean and SE were estimated using ANCOVA model.
| mL/min/1.73m^2 | Tesevatinib | Placebo |
|---|---|---|
| Month 12 | -6.8032 ± 1.2293 | -2.1780 ± 1.1709 |
| Month 18 | -7.3626 ± 1.6645 | -3.8950 ± 1.6971 |
| Month 24 | -9.7307 ± 1.4708 | -6.4070 ± 1.4138 |
| End of study | -3.2757 ± 0.5990 | -3.7497 ± 0.6323 |
Collected over From Baseline (Day 1) up to 30 days post last dose of the study drug (i.e., up to 26 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tesevatinib | 0/38 (0%) | 6/38 (15.8%) | 37/38 (97.4%) |
| Placebo | 0/40 (0%) | 2/40 (5%) | 40/40 (100%) |
| Event | Tesevatinib | Placebo |
|---|---|---|
| Renal cyst infectionInfections and infestations | 1/38 | 0/40 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/38 | 0/40 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 1/38 | 0/40 |
| Coronary artery diseaseCardiac disorders | 1/38 | 0/40 |
| Retinal detachmentEye disorders | 1/38 | 0/40 |
| Colitis ulcerativeGastrointestinal disorders | 1/38 | 0/40 |
| DehydrationMetabolism and nutrition disorders | 1/38 | 0/40 |
| AppendicitisInfections and infestations | 0/38 | 1/40 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/38 | 1/40 |
| Event | Tesevatinib | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 21/38 | 13/40 |
| NauseaGastrointestinal disorders | 14/38 | 6/40 |
| HeadacheNervous system disorders | 13/38 | 9/40 |
| Viral upper respiratory tract infectionInfections and infestations | 12/38 | 12/40 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 12/38 | 4/40 |
| DizzinessNervous system disorders | 12/38 | 0/40 |
| RashSkin and subcutaneous tissue disorders | 9/38 | 6/40 |
| VomitingGastrointestinal disorders | 7/38 | 5/40 |
| Upper respiratory tract infectionInfections and infestations | 7/38 | 6/40 |
| Flank painMusculoskeletal and connective tissue disorders | 7/38 | 4/40 |
Analysis was performed on modified Intent-To-Treat (mITT) population which included all randomized participants who receive at least 1 dose of study drug.
| Age, Continuous(years) | Tesevatinib | Placebo | Total |
|---|---|---|---|
| Mean | 47.0 ± 9.6 | 45.6 ± 10.0 | 46.3 ± 9.7 |
| Sex: Female, Male(Participants) | Tesevatinib | Placebo | Total |
|---|---|---|---|
| Female | 24 | 18 | 42 |
| Male | 14 | 22 | 36 |
| Race (NIH/OMB)(Participants) | Tesevatinib | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 32 | 33 | 65 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Ran from Oct 2017 to primary completion in Jan 2022, 51 months.
Results were first posted in Feb 2023, 1 year after primary completion.
Of 17 phase 2 interventional studies under Polycystic Kidney, Autosomal Dominant, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's 51 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: XL647
Polycystic Kidney, Autosomal Dominant →