An Early Phase 1 interventional study of Hydralazine in Polycystic Kidney Diseases, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by University of Kansas Medical Center · Early Phase 1, Interventional, and Basic science
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 32 studies in Polycystic Kidney Diseases with a site in United States — 9 open to participants now, 9 under way, 1 of them phase 3. Polycystic Kidney Diseases · United States.
Among the 32 studies in Polycystic Kidney Diseases with a site in United States, this one is the 18th largest by enrollment of the 21 interventional ones that give a count, is the only one that started in 2018, is one of 2 in phase 1, and was the 24th registered.
59 studies on the registry are indexed under Polycystic Kidney Diseases; 12 are open to participants now.
Browse Polycystic Kidney Diseases studies →9 of the 32 studies in Polycystic Kidney Diseases with a site in United States are open now. Recruiting first, the newest first:
Richard Fatica · Sites in United States
Ages 18+
Fetal Care Center, PLLC · Sites in United States
Women only
Ohio State University · Sites in United States
Ages 18–65
Otsuka Pharmaceutical Development & Commercialization, Inc. · Sites in United States, Belgium, Germany and 3 more countries
Ages 28 days–18 yrs
PKD Foundation · Sites in United States
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 11 Polycystic Kidney Diseases studies recruiting now, 6 (55%) set no upper age limit and 5 (45%) stop at 75 or younger; 5 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 65 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.
32 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 3 · Phase 2 11 · Phase 3 4
First in 2002; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 14 is below the median of 42 across 36 interventional studies indexed under Polycystic Kidney Diseases.
Median enrollment 25 across the 21 interventional studies, 300 across the 10 observational. Of the 21 that completed or were terminated, 10 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 32 have an industry lead sponsor. The 10 most frequent:
University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
University of Kansas Medical Center has 3 studies filed under Polycystic Kidney Diseases — fewer than ten, so there is no comparison to draw.
2 of the studies in Polycystic Kidney Diseases 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 |
|---|---|
| NCT06325644Ohio State UniversityWell-Formulated Ketogenic Diet Polycystic Kidney Disease | 2026-12-01 |
| NCT07454174Richard FaticaMetabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease | 2027-02 |
Add all 2 to your calendar (.ics) → With an account.
Among the 32 studies in Polycystic Kidney Diseases 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 purpose of this study is to find a protein (ex. Polycystin 1 or mucin and cadherin like protein) in the urine that is changed after treatment of hydralazine.
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.
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.
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.
Participants will take hydralazine twice daily for total of 6 weeks. The dose of hydralazine will be increased every 2 weeks.
Drug: Hydralazine
Participants will be asked to take pills two times per day for 6 weeks. This is a dose increasing study with potential doses ranging from 5 mg two times per day to 50 mg two times per day.
Change in polycystin-1 (PC1)
Time frame: Change from Baseline to Week 8
Change in mucin-like protocadherin (MUPCDH)
Time frame: Change from Baseline to Week 8
Circulating methylated RASAL1 levels
Time frame: Change from Baseline to Week 8
Ran from Apr 2018 to primary completion in Jan 2020, 21 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hydralazine
University of Kansas Medical Center →