A Phase 2 interventional study of Leuprorelin in Polycystic Liver Disease and Autosomal Dominant Polycystic Kidney, sponsored by University Medical Center Groningen. Recruiting at 2 sites in Netherlands. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by University Medical Center Groningen · Phase 2, Interventional, and Treatment
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Among 23 studies in Polycystic Kidney, Autosomal Dominant with a site in Netherlands — 4 open to participants now, 8 under way, 3 of them phase 3. Polycystic Kidney, Autosomal Dominant · Netherlands.
Among the 23 studies in Polycystic Kidney, Autosomal Dominant with a site in Netherlands, this one is the 16th largest by planned enrollment of the 20 interventional ones that give a count, is one of 4 that started in 2022, is one of 6 in phase 2, and was the 18th 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 →4 of the 23 studies in Polycystic Kidney, Autosomal Dominant with a site in Netherlands are open now. Recruiting first, the newest first:
University of Cologne · Sites in Netherlands, Austria, Germany and 1 more country
Ages 18–60
Calico Life Sciences LLC · Sites in Netherlands, United States, Australia and 9 more countries
Ages 18–55
University Medical Center Groningen · Sites in Netherlands, Austria, Belgium and 4 more countries
Ages 18–80
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
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 45 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 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 1 · Phase 2 9 · Phase 3 10 · Phase 4 1
First in 2007; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 36 is below the median of 51 across 138 interventional studies indexed under Polycystic Kidney, Autosomal Dominant.
Median enrollment 79 across the 20 interventional studies, 1,100 across the 3 observational. Of the 11 that completed or were terminated, 7 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 23 have an industry lead sponsor. The 10 most frequent:
University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 175 are open to participants now.
University Medical Center Groningen has 3 studies filed under Polycystic Kidney, Autosomal Dominant — fewer than ten, so there is no comparison to draw.
4 of the studies in Polycystic Kidney, Autosomal Dominant with a site in Netherlands that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06747572Vertex Pharmaceuticals IncorporatedPolycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease | 2026-12-31 |
| NCT05478083University Medical Center GroningenA GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease | 2027-06-01 |
| NCT07161037Vertex Pharmaceuticals IncorporatedPhase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW) | 2027-07-22 |
| NCT06734234GlaxoSmithKlineA Study to Evaluate the Safety, Tolerability, and Effects on Blood and Urine Markers of Single Ascending Dose of GSK4771261 in Healthy Participants and Participants With Autosomal Dominant Polycystic Kidney Disease | 2027-07-23 |
Add all 4 to your calendar (.ics) → With an account.
Among the 23 studies in Polycystic Kidney, Autosomal Dominant with a site in Netherlands, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Multicenter trial on the effect of the GnRH analogue leuprorelin on the growth of total liver volume in pre-menopausal women with very severe polycystic liver disease who, despite available therapy, experience growth and are heading for liver transplantation.
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.
Very large liver for age, defined as the upper 10% of liver volumes in specific age categories (based on a retrospective polycystic liver disease registry, n=1.600 patients)
Since somatostatin analogues are proven efficacious therapy for polycystic liver disease at this time it is required that:
Exclusion Criteria:
status or (vasomotor) symptoms indicating upcoming menopause
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
36 months of treatment with study medication
Drug: Leuprorelin
First 18 months standard care, hereafter 18 months treatment with study medication
Drug: Leuprorelin
Treatment consist of leuprorelin 3.75 mg once monthly for the first 3 months followed by 3-monthly injections of 11.25 mg. The direct start group will use leuprorelin for 36 months. The delayed start group will use standard of care in the first 18 months.
Liver growth
Liver volumes (in % per year) measured in the MRI at screening, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Polycystic liver disease related complaints
PLD related complaints assessed by the Polycystic liver disease-Questionnaire at baseline, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Menopause related complaints
Menopause related complaints by using the validated MENQOL questionnaire at baseline, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Patient reported mental health
Quality of life and as subset mental health will be measured by the validated RAND SF-36 questionnaires at baseline, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Patient reported physical health
Quality of life and as subset physical health will be measured by the validated RAND SF-36 questionnaires at baseline, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Kidney growth
Kidney volumes (in % per year) measured in the MRI at screening, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Sex hormone levels
Anti Muller Hormone will be assessed at screening. Other Extensive laboratory includes estradiol, progesterone, AMH, FSH, LH levels at baseline, 6 months after start therapy and after 18 and 36 months.
Time frame: 36 months
Bone density
Bone density measured by a DEXA scan at screening, 18 months and 36 months.
Time frame: 36 months
Renal function
eGFR measurements and 24h urine analyisis (in ADPKD patients only) at baseline, 6 months, 18 months, 24 months and 36 months time
Time frame: 36 months
Bloodpressure
Manual blood pressure measurements in millimetres of mercury (measure 3 times with 2 minutes in between) at screening, baseline, 3 months, 6 months, 12 months, 18months, 21 months, 24 months, 30 months and 36 months .
Time frame: 36 months
Heart rate
Heart rate in beats per minute (measure 3 times with 2 minutes in between) measured at screening, baseline, 3 months, 6 months, 12 months, 18months, 21 months, 24 months, 30 months and 36 months .
Time frame: 36 months
Weight
Body weight in kilograms measured at screening, baseline, 3 months, 6 months, 12 months, 18months, 21 months, 24 months, 30 months and 36 months .
Time frame: 36 months
Upper-arm-circumference
Upper-arm-circumference in centimeters of the non-dominant arm measured at screening, baseline, 3 months, 6 months, 12 months, 18months, 21 months, 24 months, 30 months and 36 months.
Time frame: 36 months
Abdominal circumference
Abdominal circumference in centimeters (measured at the level of the umbilicus) measured at screening, baseline, 3 months, 6 months, 12 months, 18months, 21 months, 24 months, 30 months and 36 months . At screening, length will be collected to calculate Body Mass Index.
Time frame: 36 months
Length
At screening length in centimeters will be collected.
Time frame: 1 month
The number of participants experciencing a (serious) adverse events
During each physical or telephone contact, the adverse effects are queried and registered in accordance with national protocol
Time frame: 36 months
Symptoms of depression
Symptoms of depression measured by the validated BD-II questionnaires at baseline, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Jun 2027, 60 months after the start.
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 planned 60 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Leuprolide
Polycystic Kidney, Autosomal Dominant →
University Medical Center Groningen →