Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease

• Sponsor: FibroGen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01630889
• Collaborator: AstraZeneca (Industry), Astellas Pharma Inc (Industry)
• Enrollment: 15
• Locations: 7
• Arm: 1
• Actual Duration (Months): 90.8
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease; End Stage Renal Disease; Anemia	Drug: Roxadustat	Phase 2

Detailed Description

This is an open-label, long-term maintenance study of roxadustat anemia therapy in participants with dialysis and non-dialysis CKD who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study. Participants assigned to roxadustat in the previous study will continue to receive the same roxadustat dose and dosing frequency, unless a dose adjustment is required.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label Extension Study to Evaluate the Efficacy and Safety of FG-4592 for the Long-Term Maintenance Treatment of Anemia in Dialysis and Non-Dialysis Patients With Chronic Kidney Disease
• Actual Study Start Date: May 18, 2012
• Actual Primary Completion Date: Dec 12, 2019
• Actual Study Completion Date: Dec 12, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Roxadustat Participants previously randomized to roxadustat will receive roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments will be implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 grams (g)/deciliter (dL). However, if a participant, at any dose, experiences an event of excessive hematopoiesis then the participant's dose will be immediately reduced, or an event of rapidly declining Hb then the participant's dose will be immediately increased. Participants will be permitted to receive roxadustat for up to 8 years.

Drug: Roxadustat; Oral capsule; Other Names: FG-4592

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Hb Over Time [Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384]

   Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. The specific duration over which the participants were assessed was identified as "over time" for the endpoint in the study protocol. Therefore, to be consistent with the endpoint in the study protocol, an individual timepoint was not identified for this primary outcome measure.

Secondary Outcome Measures

1. Number of Participants With Hb ≥10 g/dL [Baseline up to Week 384]

   Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting.

2. Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA]) [Baseline up to Week 385]

3. Mean Weekly Dose of Study Drug Over Time [Baseline up to Week 384]

   Weekly dose amount was the actual total dose amounts within a week, windowed by 7-day period from Day 1. The mean weekly dose is presented for selected time periods based on timepoints reported in Outcome Measures 1 and 2.

4. Number of Participants With Dose Adjustments up to Week 52 [Baseline up to Week 52]

   Dose adjustments include dose increases, dose interruptions, and dose reductions.

5. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [Baseline up to Week 385]

   An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Minimum age 18 years

2. Completed the Treatment Period of an ongoing roxadustat FibroGen-sponsored anemia study in the United States.

Exclusion Criteria

1. Participants assigned to epoetin alfa in a previous ongoing roxadustat anemia study

2. Pregnant or breastfeeding females

3. Females of childbearing potential, unless using adequate contraception; male participants with sexual partners of childbearing potential who are not on birth control unless the male participant agrees to use adequate contraception

4. Participants who received roxadustat in a previous study that did not demonstrate adequate hemoglobin response per the investigator's clinical judgment

5. Any medical condition that in the opinion of the investigator may pose a safety risk to a participant in this study or which may interfere with study participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	APEX Research	Riverside	California	United States	92505
2		Greenbelt	Maryland	United States	20770
3	Mountain Kidney & HTN Associates, PA	Asheville	North Carolina	United States	28801
4	Arlington Nephrology	Arlington	Texas	United States	76015
5	Consolidated Medical Plaza	Caguas		Puerto Rico	00725
6	CAIMED School of Medicine	Ponce		Puerto Rico	00716
7		San Juan		Puerto Rico	00918

Sponsors and Collaborators

• FibroGen
• AstraZeneca
• Astellas Pharma Inc

Investigators

• Study Director: Peony Yu, FibroGen

Study Documents (Full-Text)

• Study Protocol - Jul 25, 2018
• Statistical Analysis Plan - Mar 2, 2020

More Information

Publications

None provided.

• Responsible Party: FibroGen
• ClinicalTrials.gov Identifier: NCT01630889
• Other Study ID Numbers: FGCL-4592-059
• First Posted: Jun 28, 2012
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by FibroGen: Kidney; ESRD; End Stage Renal Disease; Anemia; Oral anemia treatment; Hemoglobin levels; Hemodialysis; CKD; Chronic Kidney Disease; Peritoneal; HD; PD; Hb; Erythropoietin; Blood count
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anemia

Study Results

Participant Flow

Arm/Group Title	Roxadustat
Arm/Group Description	Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 grams (g)/deciliter (dL). However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining hemoglobin (Hb) then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
Period Title: Overall Study
STARTED	15
Received at Least 1 Dose of Study Drug	15
COMPLETED	5
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Roxadustat
Arm/Group Description	Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
Overall Participants	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.6 (12.02)
Sex: Female, Male (Count of Participants)
Female	10 66.7%
Male	5 33.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 40%
Not Hispanic or Latino	9 60%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 6.7%
White	13 86.7%
More than one race	1 6.7%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Hb Over Time
Description	Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. The specific duration over which the participants were assessed was identified as "over time" for the endpoint in the study protocol. Therefore, to be consistent with the endpoint in the study protocol, an individual timepoint was not identified for this primary outcome measure.
Time Frame	Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
Measure Participants	15
Baseline	10.05 (0.931)
Change at Week 8	1.26 (0.633)
Change at Week 24	1.58 (0.959)
Change at Week 48	1.94 (1.324)
Change at Week 72	2.54 (1.234)
Change at Week 96	1.18 (1.141)
Change at Week 120	1.61 (0.815)
Change at Week 144	1.96 (0.804)
Change at Week 168	1.40 (1.441)
Change at Week 192	1.02 (1.063)
Change at Week 216	1.34 (1.062)
Change at Week 240	1.02 (0.779)
Change at Week 264	1.63 (1.640)
Change at Week 288	0.00 (1.647)
Change at Week 312	0.23 (0.416)
Change at Week 336	0.70 (0.000)
Change at Week 360	-1.20 (NA)
Change at Week 384	-0.40 (NA)

2. Secondary Outcome

Title	Number of Participants With Hb ≥10 g/dL
Description	Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting.
Time Frame	Baseline up to Week 384

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
Measure Participants	15
Baseline	9 60%
Week 8	13 86.7%
Week 24	13 86.7%
Week 48	13 86.7%
Week 72	11 73.3%
Week 96	7 46.7%
Week 120	8 53.3%
Week 144	7 46.7%
Week 168	5 33.3%
Week 192	5 33.3%
Week 216	5 33.3%
Week 240	5 33.3%
Week 264	4 26.7%
Week 288	3 20%
Week 312	3 20%
Week 336	2 13.3%
Week 360	1 6.7%
Week 384	1 6.7%

3. Secondary Outcome

Title	Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA])
Time Frame	Baseline up to Week 385

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
Measure Participants	15
Blood Transfusion	1 6.7%
IV Iron	5 33.3%
ESA	1 6.7%
No Rescue Therapy	8 53.3%

4. Secondary Outcome

Title	Mean Weekly Dose of Study Drug Over Time
Description	Weekly dose amount was the actual total dose amounts within a week, windowed by 7-day period from Day 1. The mean weekly dose is presented for selected time periods based on timepoints reported in Outcome Measures 1 and 2.
Time Frame	Baseline up to Week 384

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
Measure Participants	15
Week 1-4	257.0 (140.33)
Week 5 - 8	252.4 (115.26)
Week 21 - 24	282.3 (218.07)
Week 41 - 48	318.4 (216.90)
Week 61 - 72	236.7 (108.57)
Week 85 - 96	155.9 (114.27)
Week 109 - 120	142.8 (105.10)
Week 133 - 144	140.3 (101.03)
Week 157 - 168	152.2 (111.19)
Week 181 - 192	195.6 (184.77)
Week 205 - 216	209.4 (156.13)
Week 229 - 240	225.7 (164.58)
Week 253 - 264	327.9 (169.82)
Week 277 - 288	324.0 (190.75)
Week 301 - 312	319.2 (196.98)
Week 325 - 336	413.3 (180.37)
Week 349 - 360	389.6 (156.15)
Week 373 - 384	250.0 (NA)

5. Secondary Outcome

Title	Number of Participants With Dose Adjustments up to Week 52
Description	Dose adjustments include dose increases, dose interruptions, and dose reductions.
Time Frame	Baseline up to Week 52

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
Measure Participants	15
Participants without Change	1 6.7%
Participants with 1 Dose Increase	5 33.3%
Participants with 2 Dose Increases	1 6.7%
Participants with >2 Dose Increases	6 40%
Participants with 1 Dose Interruption	1 6.7%
Participants with 2 Dose Interruptions	1 6.7%
Participants with >2 Dose Interruptions	0 0%
Participants with 1 Dose Reduction	2 13.3%
Participants with 2 Dose Reductions	8 53.3%
Participants with >2 Dose Reductions	2 13.3%

6. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Description	An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame	Baseline up to Week 385

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
Measure Participants	15
Any TEAEs	14 93.3%
Serious TEAEs	9 60%

Adverse Events

Time Frame	Baseline up to Week 385
Adverse Event Reporting Description	Participants who received at least 1 dose of study drug.
Arm/Group Title	Roxadustat
Arm/Group Description	Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
All Cause Mortality
	Roxadustat
	Affected / at Risk (%)	# Events
Total	2/15 (13.3%)
Serious Adverse Events
	Roxadustat
	Affected / at Risk (%)	# Events
Total	9/15 (60%)
Blood and lymphatic system disorders
Hemorrhagic anaemia	1/15 (6.7%)
Cardiac disorders
Acute coronary syndrome	1/15 (6.7%)
Acute myocardial infarction	2/15 (13.3%)
Angina pectoris	2/15 (13.3%)
Angina unstable	1/15 (6.7%)
Atrial fibrillation	2/15 (13.3%)
Cardiac failure	1/15 (6.7%)
Cardiac failure congestive	2/15 (13.3%)
Ventricular fibrillation	1/15 (6.7%)
Gastrointestinal disorders
Epiploic appendagitis	1/15 (6.7%)
General disorders
Gait disturbance	1/15 (6.7%)
Infections and infestations
Cellulitis	1/15 (6.7%)
Clostridium difficile colitis	1/15 (6.7%)
Pneumonia	2/15 (13.3%)
Sepsis	1/15 (6.7%)
Urinary tract infection	2/15 (13.3%)
Injury, poisoning and procedural complications
Fall	1/15 (6.7%)
Humerus fracture	1/15 (6.7%)
Wound haemorrhage	1/15 (6.7%)
Metabolism and nutrition disorders
Hyperkalemia	1/15 (6.7%)
Nervous system disorders
Hypoxic-ischaemic encephalopathy	1/15 (6.7%)
Renal and urinary disorders
Chronic kidney disease	2/15 (13.3%)
Renal tubular necrosis	1/15 (6.7%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/15 (6.7%)
Respiratory failure	1/15 (6.7%)
Vascular disorders
Shock hemorrhagic	1/15 (6.7%)
Other (Not Including Serious) Adverse Events
	Roxadustat
	Affected / at Risk (%)	# Events
Total	14/15 (93.3%)
Blood and lymphatic system disorders
Anaemia	1/15 (6.7%)
Iron deficiency anaemia	1/15 (6.7%)
Cardiac disorders
Atrial fibrillation	2/15 (13.3%)
Palpitations	1/15 (6.7%)
Ear and labyrinth disorders
Vertigo	1/15 (6.7%)
Endocrine disorders
Hypothyroidism	1/15 (6.7%)
Eye disorders
Cataract	2/15 (13.3%)
Gastrointestinal disorders
Abdominal hernia	1/15 (6.7%)
Abdominal pain	3/15 (20%)
Constipation	1/15 (6.7%)
Diarrhoea	1/15 (6.7%)
Dyspepsia	1/15 (6.7%)
Gastritis	1/15 (6.7%)
Haemorrhoids	1/15 (6.7%)
Nausea	2/15 (13.3%)
Toothache	1/15 (6.7%)
Umbilical hernia	1/15 (6.7%)
Vomiting	1/15 (6.7%)
General disorders
Chest pain	1/15 (6.7%)
Injection site rash	1/15 (6.7%)
Non-cardiac chest pain	1/15 (6.7%)
Oedema	1/15 (6.7%)
Oedema peripheral	2/15 (13.3%)
Infections and infestations
Abdominal infection	1/15 (6.7%)
Abscess limb	1/15 (6.7%)
Bronchitis	3/15 (20%)
Cellulitis	2/15 (13.3%)
Chikungunya virus infection	1/15 (6.7%)
Diverticulitis	1/15 (6.7%)
Influenza	2/15 (13.3%)
Localised infection	1/15 (6.7%)
Mastoiditis	1/15 (6.7%)
Nail infection	1/15 (6.7%)
Onychomycosis	1/15 (6.7%)
Pneumonia	2/15 (13.3%)
Tinea pedis	1/15 (6.7%)
Upper respiratory tract infection	6/15 (40%)
Urinary tract infection	3/15 (20%)
Vaginal infection	1/10 (10%)
Viral upper respiratory tract infection	3/15 (20%)
Vulvovaginal candidiasis	1/10 (10%)
Injury, poisoning and procedural complications
Bone contusion	1/15 (6.7%)
Contusion	1/15 (6.7%)
Laceration	1/15 (6.7%)
Ligament sprain	1/15 (6.7%)
Limb injury	1/15 (6.7%)
Muscle strain	1/15 (6.7%)
Procedural nausea	1/15 (6.7%)
Procedural pain	1/15 (6.7%)
Rib fracture	1/15 (6.7%)
Skin abrasion	2/15 (13.3%)
Fall	1/15 (6.7%)
Humerus fracture	1/15 (6.7%)
Investigations
Blood pressure increased	2/15 (13.3%)
Platelet count decreased	1/15 (6.7%)
Serum ferritin decreased	1/15 (6.7%)
Metabolism and nutrition disorders
Dehydration	1/15 (6.7%)
Gout	3/15 (20%)
Hyperglycaemia	1/15 (6.7%)
Hyperkalaemia	1/15 (6.7%)
Hyperlipidaemia	1/15 (6.7%)
Hypermagnesaemia	1/15 (6.7%)
Hyperphosphataemia	2/15 (13.3%)
Hyperuricaemia	1/15 (6.7%)
Hypoalbuminaemia	1/15 (6.7%)
Hypoglycaemia	3/15 (20%)
Hypomagnesaemia	1/15 (6.7%)
Iron deficiency	2/15 (13.3%)
Vitamin B12 deficiency	1/15 (6.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/15 (6.7%)
Arthritis	1/15 (6.7%)
Back pain	1/15 (6.7%)
Exostosis	1/15 (6.7%)
Joint swelling	1/15 (6.7%)
Muscle spasms	3/15 (20%)
Musculoskeletal pain	2/15 (13.3%)
Osteoporosis	1/15 (6.7%)
Pain in extremity	1/15 (6.7%)
Torticollis	1/15 (6.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer	1/15 (6.7%)
Seborrhoeic keratosis	1/15 (6.7%)
Nervous system disorders
Diabetic neuropathy	1/15 (6.7%)
Headache	1/15 (6.7%)
Migraine	1/15 (6.7%)
Neuralgia	2/15 (13.3%)
Product Issues
Thrombosis in device	1/15 (6.7%)
Psychiatric disorders
Depression	2/15 (13.3%)
Insomnia	1/15 (6.7%)
Mental status changes	1/15 (6.7%)
Renal and urinary disorders
Renal impairment	1/15 (6.7%)
Reproductive system and breast disorders
Pelvic pain	1/10 (10%)
Vaginal haemorrhage	2/10 (20%)
Respiratory, thoracic and mediastinal disorders
Asthma	2/15 (13.3%)
Bronchospasm	1/15 (6.7%)
Cough	5/15 (33.3%)
Nasal congestion	1/15 (6.7%)
Organising pneumonia	1/15 (6.7%)
Oropharyngeal pain	1/15 (6.7%)
Respiratory tract congestion	1/15 (6.7%)
Rhinorrhoea	1/15 (6.7%)
Sleep apnoea syndrome	1/15 (6.7%)
Skin and subcutaneous tissue disorders
Alopecia	1/15 (6.7%)
Blister	1/15 (6.7%)
Ingrowing nail	1/15 (6.7%)
Skin disorder	1/15 (6.7%)
Stasis dermatitis	1/15 (6.7%)
Social circumstances
Loss of personal independence in daily activities	1/15 (6.7%)
Vascular disorders
Deep vein thrombosis	1/15 (6.7%)
Hypertension	2/15 (13.3%)
Hypotension	2/15 (13.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).