Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-PR141606 | Other Identifier | US Army Medical Research and Materiel Command |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tufts Medical Center | OTHER |
| University of Maryland, Baltimore | OTHER |
| University of Southern California | OTHER |
| United States Department of Defense |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will test to see if metformin is safe and if it is tolerated compared to placebo in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages of chronic kidney disease. We will also measure its effect on progression of kidney disease as reflected in the kidney size and the kidney function, along with its effect on kidney pain and quality of life.
There is growing evidence that metformin, a drug widely used for the treatment of type 2 diabetes and polycystic ovary syndrome, may serve as a novel therapy for individuals in the early stages of Autosomal Dominant Polycystic Kidney Disease ADPKD by activating the metabolic sensor AMP-activated protein kinase (AMPK). AMPK is activated under conditions of metabolic and other cellular stresses. Through its actions on downstream mediators, AMPK activation during low energy states decreases cellular energy consumption while stimulating energy generating pathways. It has been shown that AMPK phosphorylates and inhibits cystic fibrosis transmembrane conductance regulator (CFTR), thus suppressing epithelial fluid and electrolyte secretion. Similarly, AMPK phosphorylates the tuberin protein, leading to indirect inhibition of the mTOR pathway. Thus, AMPK inhibits both CFTR and mTOR, suggesting that targeted activation of this kinase by metformin may provide a therapeutic benefit in ADPKD. It has been shown that metformin treatment of kidney epithelial cells leads to stimulation of AMPK and subsequent inhibition of both mTOR and CFTR activity. It has also been shown that metformin slows cystogenesis in animal models of PKD, supporting the potential of this drug in ADPKD treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | Participants will be started on 500 mg of metformin once daily, with the following scheduled dose titrations:
|
|
| Placebo | Placebo Comparator | Participants will be started on 500 mg of placebo once daily, with the following scheduled dose titrations:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Monitoring of tolerability and symptoms. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Gastrointestinal Symptoms Rating Scale (GSRS) to 24 Months | GSRS is a widely used, validated 15-item questionnaire used to assess GI symptom burden (minimum, maximum: 1, 7, where higher mean score is worse outcome). Mean change to 24 months, estimated with a repeated measures analysis (baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. | Baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months |
| Drug Tolerability | Tolerability was based on the first visit a participant responded no to the following question "Can you tolerate this dose of study drug the rest of your life?", which was asked at baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months. | Baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months |
| Rate of Serious Adverse Events (SAE) | Serious adverse events (SAE) occurring from the time a participant signs the informed consent (at the screening visit) until the end of the study, meeting 1 or more of the criteria of: 1) Resulting in death, 2) Non-elective hospitalization, 3) Life threatening (if patient continued on study drug would result in death), 4) Harming or disabling persistently or permanently , 5) Exceeding the nature, severity or frequency of risk described in the protocol or 6) Resulting in congenital anomaly. | 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Physical Component | Short Form-36 Quality of Life Physical Component Summary (SF-36 PCS) ranges from 0 (worst possible outcome) to 100 (best possible outcome). Mean change to 24 months, estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
Not provided
Inclusion Criteria:
Subject has Autosomal Dominant Polycystic Kidney Disease; Subject is fluent in English
Exclusion Criteria:
Subject is not on active military duty; Subject is not currently participating in another clinical trial; Subject's current GFR is not <50 cc/min/1.73m2; Subject does not have diabetes; Subject does not have a systemic disease other than hypertension and PKD; Subject does not have a solitary kidney; Subject does not have an allergy or intolerance to metformin; Subject is not pregnant or lactating or intending to become pregnant within the next three years; Subject does not have an unstable or unclipped cerebral aneurysm; Subject does not have active coronary artery disease; Subject does not have an MRI incompatible device/implant; Subject does not have severe claustrophobia; Subject has not had any solid organ transplant; Subject does not have a Vitamin B12 deficiency; Subject does not currently take any medications that interact with metformin, such as nifedipine, furosemide, cationic drugs (amiloride, ranitidine, triamterene digoxin, procainamide, quinidine, vancomycin, trimethoprim); Subject does not currently take nor has taken (within 2 weeks) the drug tolvaptan (Jynarque or Samsca)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyongtae Bae, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States | ||
| Tufts Medical Center |
| 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. | |
| 38837240 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Metformin | Participants will be started on 500 mg of metformin once daily, with the following scheduled dose titrations:
Metformin: Monitoring of tolerability and symptoms. |
| FG001 | Placebo | Participants will be started on 500 mg of placebo once daily, with the following scheduled dose titrations:
Placebo: Monitoring of tolerability and symptoms. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Metformin | Participants will be started on 500 mg of metformin once daily, with the following scheduled dose titrations:
Metformin: Monitoring of tolerability and symptoms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in the Gastrointestinal Symptoms Rating Scale (GSRS) to 24 Months | GSRS is a widely used, validated 15-item questionnaire used to assess GI symptom burden (minimum, maximum: 1, 7, where higher mean score is worse outcome). Mean change to 24 months, estimated with a repeated measures analysis (baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months |
|
Adverse event were data collected at 2, 4, and 6 weeks during the titration period and every 3 months thereafter through 26 months.
Adverse events and deaths were not collected by dose level.
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 | Metformin | Participants will be started on 500 mg of metformin once daily, with the following scheduled dose titrations:
Metformin: Monitoring of tolerability and symptoms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other - diarrhea (c. difficile infection) | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyongtae Bae | University of Pittsburgh | 412-647-3500 | baek@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2018 | Dec 1, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2018 | May 8, 2019 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| D007674 | Kidney Diseases |
| D007690 | Polycystic Kidney Diseases |
| ID | Term |
|---|---|
| D052177 | Kidney Diseases, Cystic |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| FED |
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Monitoring of tolerability and symptoms. |
|
| Quality of Life Mental Component | Short Form-36 Quality of Life Mental Component Summary (SF-36 MCS) ranges from 0 (worst possible outcome) to 100 (best possible outcome). Mean change to 24 months, estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
| Back Pain Frequency Over the Past 3 Months Since Last Visit | Odds ratio (OR) per month of back pain Often, Usually, or Always (vs. Never, Rarely, Sometimes) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
| Estimated Glomerular Filtration Rate (eGFR) | Mean change to 24 months, estimated with a repeated measures analysis (baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. | Baseline, 2 weeks, and 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months |
| Total Kidney Volume From Magnetic Resonance Imaging | Annual percent change of height adjusted and natural log transformed total kidney volume [ln(htTKV)] was estimated with a linear mixed model. | Baseline, 6 months, 12 months, 18 months, 24 months |
| Total Kidney Cyst Volume From Magnetic Resonance Imaging | Annual percent change of height adjusted and natural log transformed total kidney cyst volume [ln(htTKCV)] was estimated with a linear mixed model. | Baseline, 6 months, 12 months, 18 months, 24 months |
| Liver Volume From Magnetic Resonance Imaging | Annual percent change of height adjusted and natural log transformed liver volume [ln(htLV)] was estimated with a linear mixed model. | Baseline, 6 months, 12 months, 18 months, 24 months |
| Liver Cyst Volume From Magnetic Resonance Imaging | Annual percent change of height adjusted and natural log transformed liver cyst volume [ln(htLCV)] was estimated with a linear mixed model. | Baseline, 6 months, 12 months, 18 months, 24 months |
| Frequency Abdominal Fullness Interfered With Ability to Perform Usual Physical Activity Over the Past 3 Months Since Last Visit. | Odds ratio (OR) per month of abdominal fullness interfered Often, Usually, or Always (vs. Never, Rarely, Sometimes) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
| Interference of Pain With Sleep Over the Past 3 Months Since Last Visit | Odds ratio (OR) per month of pain interfered with sleep Quite a bit or Extremely (vs. Not at all, A little bit, Moderately) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
| Interference of Pain With Strenuous Physical Activity Over the Past 3 Months Since Last Visit | Odds ratio (OR) per month of pain interfered with strenuous physical activity Quite a bit or Extremely (vs. Not at all, A little bit, Moderately) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
| Boston |
| Massachusetts |
| 02111 |
| United States |
| El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2. |
| 33768205 | Derived | Seliger SL, Watnick T, Althouse AD, Perrone RD, Abebe KZ, Hallows KR, Miskulin DC, Bae KT. Baseline Characteristics and Patient-Reported Outcomes of ADPKD Patients in the Multicenter TAME-PKD Clinical Trial. Kidney360. 2020 Dec 31;1(12):1363-1372. doi: 10.34067/KID.0004002020. |
| Unable/unwilling to take study medication |
|
| Began Tolvaptan |
|
| Withdrawal by Subject |
|
| BG001 | Placebo | Participants will be started on 500 mg of placebo once daily, with the following scheduled dose titrations:
Placebo: Monitoring of tolerability and symptoms. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PKD genotype | Count of Participants | Participants |
|
| GFR | Mean | Standard Deviation | (ml/min/1.73 m²) |
|
| Vitamin B12 | Mean | Standard Deviation | pg/mL |
|
| Glucose | Mean | Standard Deviation | mg/dL |
|
| HbA1c | Two participants are missing results. | Mean | Standard Deviation | % of total hemoglobin |
|
| Serum Creatinine | Mean | Standard Deviation | mg/dL |
|
| Systolic BP | Mean | Standard Deviation | mmHg |
|
| Diastolic BP | Mean | Standard Deviation | mmHg |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Gastrointestinal Symptoms Rating Scale | GSRS is a widely used, validated 15-item questionnaire used to assess GI symptom burden (minimum, maximum: 1, 7, where higher mean score is worse outcome). | Mean | Standard Deviation | scores on a scale |
|
| Short Form-36, Mental Component Summary | Short Form-36 Quality of Life Mental Component Summary (SF-36 MCS) ranges from 0 (worst possible outcome) to 100 (best possible outcome). | Mean | Standard Deviation | scores on a scale |
|
| Short Form-36, Physical Component Summary | Short Form-36 Quality of Life Physical Component Summary (SF-36 PCS) ranges from 0 (worst possible outcome) to 100 (best possible outcome). | Mean | Standard Deviation | scores on a scale |
|
| Mayo Imaging Class | For Measure Description: Imaging classification of ADPKD, where height-adjusted total kidney volume is stratified into classes on the basis of kidney size and age (class 2, 1A-1E, in increasing order of risk for eGFR decline). | Count of Participants | Participants |
|
| Height-adjusted total kidney volume | One participant missing result. | Mean | Standard Deviation | mL/m |
|
| Height-adjusted liver volume | One participant missing result. | Mean | Standard Deviation | mL/m |
|
| OG001 | Placebo | Participants will be started on 500 mg of placebo once daily, with the following scheduled dose titrations:
Placebo: Monitoring of tolerability and symptoms. |
|
|
|
| Primary | Drug Tolerability | Tolerability was based on the first visit a participant responded no to the following question "Can you tolerate this dose of study drug the rest of your life?", which was asked at baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months. | Intention to treat analysis | Posted | Count of Participants | Participants | Baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months |
|
|
|
|
| Primary | Rate of Serious Adverse Events (SAE) | Serious adverse events (SAE) occurring from the time a participant signs the informed consent (at the screening visit) until the end of the study, meeting 1 or more of the criteria of: 1) Resulting in death, 2) Non-elective hospitalization, 3) Life threatening (if patient continued on study drug would result in death), 4) Harming or disabling persistently or permanently , 5) Exceeding the nature, severity or frequency of risk described in the protocol or 6) Resulting in congenital anomaly. | Participants who received and took metformin or placebo | Posted | Count of Participants | Participants | 26 months |
|
|
|
|
| Secondary | Quality of Life Physical Component | Short Form-36 Quality of Life Physical Component Summary (SF-36 PCS) ranges from 0 (worst possible outcome) to 100 (best possible outcome). Mean change to 24 months, estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. | Intention to treat analysis | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
|
|
|
|
| Secondary | Quality of Life Mental Component | Short Form-36 Quality of Life Mental Component Summary (SF-36 MCS) ranges from 0 (worst possible outcome) to 100 (best possible outcome). Mean change to 24 months, estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. | Intention to treat analysis | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
|
|
|
|
| Secondary | Back Pain Frequency Over the Past 3 Months Since Last Visit | Odds ratio (OR) per month of back pain Often, Usually, or Always (vs. Never, Rarely, Sometimes) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. | Intention to treat analysis | Posted | Number | 95% Confidence Interval | odds ratio | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
|
|
|
|
| Secondary | Estimated Glomerular Filtration Rate (eGFR) | Mean change to 24 months, estimated with a repeated measures analysis (baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. | Intention to treat analysis | Posted | Mean | 95% Confidence Interval | ml/min/1.73m^2 | Baseline, 2 weeks, and 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months |
|
|
|
|
| Secondary | Total Kidney Volume From Magnetic Resonance Imaging | Annual percent change of height adjusted and natural log transformed total kidney volume [ln(htTKV)] was estimated with a linear mixed model. | Intention to treat analysis | Posted | Mean | 95% Confidence Interval | annual percent change | Baseline, 6 months, 12 months, 18 months, 24 months |
|
|
|
|
| Secondary | Total Kidney Cyst Volume From Magnetic Resonance Imaging | Annual percent change of height adjusted and natural log transformed total kidney cyst volume [ln(htTKCV)] was estimated with a linear mixed model. | Intention to treat analysis | Posted | Mean | 95% Confidence Interval | annual percent change | Baseline, 6 months, 12 months, 18 months, 24 months |
|
|
|
|
| Secondary | Liver Volume From Magnetic Resonance Imaging | Annual percent change of height adjusted and natural log transformed liver volume [ln(htLV)] was estimated with a linear mixed model. | Intention to treat analysis | Posted | Mean | 95% Confidence Interval | annual percent change | Baseline, 6 months, 12 months, 18 months, 24 months |
|
|
|
|
| Secondary | Liver Cyst Volume From Magnetic Resonance Imaging | Annual percent change of height adjusted and natural log transformed liver cyst volume [ln(htLCV)] was estimated with a linear mixed model. | Intention to treat analysis | Posted | Mean | 95% Confidence Interval | annual percent change | Baseline, 6 months, 12 months, 18 months, 24 months |
|
|
|
|
| Secondary | Frequency Abdominal Fullness Interfered With Ability to Perform Usual Physical Activity Over the Past 3 Months Since Last Visit. | Odds ratio (OR) per month of abdominal fullness interfered Often, Usually, or Always (vs. Never, Rarely, Sometimes) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. | Intention to treat analysis | Posted | Number | 95% Confidence Interval | odds ratio | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
|
|
|
|
| Secondary | Interference of Pain With Sleep Over the Past 3 Months Since Last Visit | Odds ratio (OR) per month of pain interfered with sleep Quite a bit or Extremely (vs. Not at all, A little bit, Moderately) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. | Intention to treat analysis | Posted | Number | 95% Confidence Interval | odds ratio | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
|
|
|
|
| Secondary | Interference of Pain With Strenuous Physical Activity Over the Past 3 Months Since Last Visit | Odds ratio (OR) per month of pain interfered with strenuous physical activity Quite a bit or Extremely (vs. Not at all, A little bit, Moderately) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. | Intention to treat analysis | Posted | Number | 95% Confidence Interval | odds ratio | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months |
|
|
|
|
| 0 |
| 49 |
| 4 |
| 49 |
| 21 |
| 49 |
| EG001 | Placebo | Participants will be started on 500 mg of placebo once daily, with the following scheduled dose titrations:
Placebo: Monitoring of tolerability and symptoms. | 0 | 48 | 4 | 48 | 13 | 48 |
| Other - bone fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Other - lightheadedness | Nervous system disorders | Non-systematic Assessment |
|
| Gastric hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
|
| Other - umbilical hernia | Surgical and medical procedures | Non-systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | Non-systematic Assessment |
|
| Other - urinary tract infection and renal cyst hemorrhage (mild) | Infections and infestations | Non-systematic Assessment |
|
| Other - renal cyst | Renal and urinary disorders | Non-systematic Assessment |
|
| Other - renal cyst rupture | Renal and urinary disorders | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Other - Loss Of Appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Other - Loose Stools | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Other - Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Other - Uti | Renal and urinary disorders | Non-systematic Assessment |
|
| Other - Kidney Pain | Renal and urinary disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
Not provided
Not provided
| 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 |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other |
|
| No mutation detected |
|
| N/A |
|
| Class 1B |
|
| Class 1C |
|
| Class 1D |
|
| Class 1E |
|
| N/A |
|