Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003764-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the trial is to compare the effectiveness and safety of 2 treatment regimens of CAM2029 (given weekly or every 2 weeks) to placebo in participants with symptomatic PLD, either isolated as in autosomal dominant PLD (ADPLD) or associated with autosomal dominant polycystic kidney disease (ADPKD).
In the Treatment Period of the trial, participants will be allocated at random to 1 of the 3 treatment arms in a 1:1:1 ratio. After completing the Treatment Period (53 weeks) participants may proceed to a 120-week open-label extension part of the trial and then only receive the same CAM2029 treatment.
The active ingredient in CAM2029, octreotide, is administered as a subcutaneous depot using Camurus' FluidCrystal® technology.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAM2029 once weekly | Experimental | 0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly |
|
| CAM2029 once every 2 weeks | Experimental | 0.5 mL CAM2029 10 mg, SC injection, every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing) |
|
| Placebo | Placebo Comparator | 0.5 mL placebo, SC injection, once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAM2029 | Drug | SC injection using a pre-filled pen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Height-adjusted Total Liver Volume (htTLV) | Magnetic resonance imaging (MRI) was used to measure the total liver volume (TLV) at baseline and at Week 53 and was adjusted to the participant's height. The change from baseline to Week 53 was calculated as the difference between htTLV values at Week 53 and baseline. The difference in treatment effect between the groups was presented as a ratio expressed in percentage. | From screening until treatment week 53 |
| Measure | Description | Time Frame |
|---|---|---|
| PLD Symptom (PLD-S) Score | Change from baseline to Week 53 in the PLD-S measure score. | From screening to Week 53 |
| htTLV | Change from baseline in htTLV as determined by MRI volumetry |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joost Drenth, MD | Department of Gastroenterology and Hepatology, Radboud UMC Nijmegen, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Mount Sinai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39356039 | Derived | St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CAM2029 Once Weekly | 0.5 mL CAM2029 10 mg, (SC) injection, once weekly |
| FG001 | CAM2029 Once Every 2 Weeks | 0.5 mL CAM2029 10 mg, SC injection,every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 20, 2025 | Mar 4, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | SC injection using a pre-filled pen |
|
| From screening until treatment weeks 13, 25, 77, 125 and 173 |
| PLD-S | Change from baseline in the PLD-S measure score | From screening to weeks 13, 21, 25, 39, 77, 101, 125, 149 and 173 |
| Height-adjusted Total Kidney Volume (htTKV) | Change from baseline in htTKV as determined by MRI volumetry | From screening until treatment weeks 13, 25, 53, 77, 125 and 173 |
| Total Liver Cyst Volume | Change from baseline in total liver cyst volume determined by MRI volumetry | From screening to treatment weeks 13, 25, 53, 77, 125 and 173 |
| Estimated Glomerular Filtration Rate (eGFR) | Change from baseline in eGFR, assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation using serum concentrations of creatinine and cystatin C | From treatment week 1 to weeks 13, 25, 53, 65, 77, 101, 125, 149 and 173 |
| PLD Impact (PLD-I) Score | Change from baseline in the PLD-I measure score | From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173 |
| Clinical Global Impression of Severity (CGI-S) Score | Change from baseline in the CGI-S score | From treatment week 1 to weeks 13, 21, 25, 53, 77, 101, 125, 149 and 173 |
| Patient Global Impression of Severity (PGI-S) Score | Change from baseline in the PGI-S score | From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173 |
| Patient Global Impression of Change (PGI-C) Score | Change from baseline in the PGI-C score | At treatment weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173 |
| Short Form-36 (SF-36) Score | Change from baseline in the SF-36 score | From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173 |
| Polycystic Liver Disease Questionnaire (PLD-Q) | Change from baseline in the PLD-Q score | From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173 |
| Adverse Events (AEs) | Incidence of AEs | From screening to the safety follow-up, assessed up to approximately 47 months. |
| New York |
| New York |
| 10029 |
| United States |
| The New York Presbyterian Hospital | New York | New York | 10065 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75380-8887 | United States |
| Bon Secours Richmond Community Hospital | Richmond | Virginia | 23602 | United States |
| University Hospitals KU Leuven | Leuven | B-3000 | Belgium |
| Hannover Medical School | Hanover | 30625 | Germany |
| Universitätsklinikum Leipzig | Leipzig | 04103 | Germany |
| Universitaetsklinikum Müenster | Münster | 48149 | Germany |
| Radboud UMC, Department of Gastroenterology and Hepatology | Nijmegen | 6525 GA | Netherlands |
| FG002 | Placebo | 0.5 mL placebo, SC injection, once weekly |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CAM2029 Once Weekly | 0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly |
| BG001 | CAM2029 Once Every 2 Weeks | 0.5 mL CAM2029 10 mg, SC injection,every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing) |
| BG002 | Placebo | 0.5 mL placebo, SC injection, once weekly |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Height-adjusted total liver volume (htTLV) | Baseline MRI scan was missing for 4 participants. | Mean | Standard Deviation | mL/m |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Height-adjusted Total Liver Volume (htTLV) | Magnetic resonance imaging (MRI) was used to measure the total liver volume (TLV) at baseline and at Week 53 and was adjusted to the participant's height. The change from baseline to Week 53 was calculated as the difference between htTLV values at Week 53 and baseline. The difference in treatment effect between the groups was presented as a ratio expressed in percentage. | Participants were randomized to three treatment groups: CAM2029 10 mg Q1W, CAM2029 10 mg Q2W, or Placebo. The primary outcome comparison was the average effect of the two CAM2029 doses (i.e., the combined CAM2029 groups) compared to placebo. The intention-to-treat analysis set (all participants randomized to a treatment arm in the double-blind period) was used for the analysis. The baseline MRI scan was missing for 4 participants (1 in each CAM2029 separate group and 2 in the placebo group). | Posted | Least Squares Mean | 95% Confidence Interval | percentage | From screening until treatment week 53 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PLD Symptom (PLD-S) Score | Change from baseline to Week 53 in the PLD-S measure score. | Not Posted | Aug 2028 | From screening to Week 53 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | htTLV | Change from baseline in htTLV as determined by MRI volumetry | Not Posted | Aug 2028 | From screening until treatment weeks 13, 25, 77, 125 and 173 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PLD-S | Change from baseline in the PLD-S measure score | Not Posted | Aug 2028 | From screening to weeks 13, 21, 25, 39, 77, 101, 125, 149 and 173 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Height-adjusted Total Kidney Volume (htTKV) | Change from baseline in htTKV as determined by MRI volumetry | Not Posted | Aug 2028 | From screening until treatment weeks 13, 25, 53, 77, 125 and 173 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Liver Cyst Volume | Change from baseline in total liver cyst volume determined by MRI volumetry | Not Posted | Aug 2028 | From screening to treatment weeks 13, 25, 53, 77, 125 and 173 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Estimated Glomerular Filtration Rate (eGFR) | Change from baseline in eGFR, assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation using serum concentrations of creatinine and cystatin C | Not Posted | Aug 2028 | From treatment week 1 to weeks 13, 25, 53, 65, 77, 101, 125, 149 and 173 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PLD Impact (PLD-I) Score | Change from baseline in the PLD-I measure score | Not Posted | Aug 2028 | From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression of Severity (CGI-S) Score | Change from baseline in the CGI-S score | Not Posted | Aug 2028 | From treatment week 1 to weeks 13, 21, 25, 53, 77, 101, 125, 149 and 173 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Severity (PGI-S) Score | Change from baseline in the PGI-S score | Not Posted | Aug 2028 | From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Change (PGI-C) Score | Change from baseline in the PGI-C score | Not Posted | Aug 2028 | At treatment weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Short Form-36 (SF-36) Score | Change from baseline in the SF-36 score | Not Posted | Aug 2028 | From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Polycystic Liver Disease Questionnaire (PLD-Q) | Change from baseline in the PLD-Q score | Not Posted | Aug 2028 | From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adverse Events (AEs) | Incidence of AEs | Not Posted | From screening to the safety follow-up, assessed up to approximately 47 months. | Participants |
From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAM2029 Once Weekly | 0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly | 0 | 24 | 2 | 24 | 24 | 24 |
| EG001 | CAM2029 Once Every 2 Weeks | 0.5 mL CAM2029 10 mg, SC injection,every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing) | 1 | 23 | 3 | 23 | 21 | 23 |
| EG002 | Placebo | 0.5 mL placebo, SC injection, once weekly | 0 | 23 | 5 | 23 | 22 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial pyelonephritis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment | Not related to intervention |
|
| Gastroenteritis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment | Not related to intervention, Grade 5 |
|
| Pneumonia | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment | Not related to intervention |
|
| Pyelonephritis acute | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment | Not related to intervention |
|
| Renal cyst infection | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment | Not related to intervention |
|
| Polycystic liver disease | Congenital, familial and genetic disorders | MedDRA (25.0) | Non-systematic Assessment | Progression of PLD. Not related to intervention. |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment | Not related to intervention |
|
| Hepatic cyst ruptured | Hepatobiliary disorders | MedDRA (25.0) | Non-systematic Assessment | Not related to intervention |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment | Not related to intervention |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (25.0) | Non-systematic Assessment | Not related to intervention |
|
| Renal cyst haemorrhage | Renal and urinary disorders | MedDRA (25.0) | Non-systematic Assessment | Not related to intervention |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Steatorrhoea | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Faeces pale | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site discolouration | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site granuloma | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Development | Camurus AB | 0046462865730 | info@camurus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2025 | Mar 4, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C536330 | Polycystic liver disease |
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
Not provided
Not provided
|
|
|
|
|