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Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

Primary Purpose

Secondary Hyperparathyroidism, Chronic Kidney Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Cinacalcet

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism, Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Dialysis, Secondary Hyperparathyroidism, Pediatric

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:

All subjects:

Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any Study 20140159 activities/procedures being initiated.
Dialysate calcium concentration ≥ 2.5 mEq/L at day 1

All subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and screening for Study 20140159:

Subjects on anti-convulsant medication must be on a stable dose

All subjects from 20130356:

Completed treatment through week 20 in the 20130356 study or on study at the time of Study 20130356 termination
Dry weight ≥ 12.5 kg at day 1 of Study 20140159

Subjects Randomized to the 20130356 Standard of Care Arm Only:

intact parathyroid hormone (iPTH) value ≥ 300 pg/mL (within 7 days of day 1 in Study 20140159)
Corrected calcium value ≥ 8.8 mg/dL within 7 days of day 1 in Study 20140159

All Subjects from 20110100:

Completed week 26 End of Study visit in the, 20110100 study or on study at the time of Study 20110100 termination
Dry weight ≥ 7 kg at day 1 of Study 20140159

EXCLUSION CRITERIA:

General (studies 20130356 and 20110100):

Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s), other than Amgen Studies 20130356 or 20110100.
Other investigational procedures while participating in this study are excluded.
Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
Subject has known sensitivity to any of the products to be administered during dosing.
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary [ediary]) to the best of the subject and investigator's knowledge
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Subject previously has entered this study.
If sexually active, subject is not willing to use acceptable contraception during treatment and for at least 9 days after the end of treatment.
Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment
History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias, or other conditions associated with prolonged QT interval
A new onset of seizures or worsening of pre-existing seizure disorder

All Subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and the screening visit in Study 20140159 will have the following exclusion criteria applied during screening and day 1:

Unstable chronic heart failure defined as worsening pulmonary edema or other signs and symptoms as per investigator assessment during screening
Received therapy with commercial cinacalcet after the last study visit in Study 20130356 or Study 20110100 before day 1 of Study 20140159
Scheduled date for kidney transplantation from a known living donor that makes completion of the study unlikely
Either new or recurrent cardiac ventricular arrhythmias requiring a change in treatment within 10 days prior to screening visit or day 1 of Study 20140159 screening
Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase [AST] ≥ 1.5 × upper limit of normal [ULN] OR alanine aminotransferase [ALT] ≥ 1.5 × ULN OR total bilirubin ≥ 1 × ULN per institutional laboratory range) during screening

All Subjects - Day 1 Study Visit:

Subject has an ongoing adverse event from Studies 20130356 or 20110100 that is considered related to investigational product and is ≥ Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0) grade 3, and/or considered clinically significant in the opinion of the investigator
Central laboratory values were not obtained/are not available at day 1 in Study 20140159
Corrected QT Interval (QTc) > 500 ms, using Bazett's formula
QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
Use of grapefruit juice, herbal medications, CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole), or CYP2D6 substrates (eg, flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine)
Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cinacalcet

Arm Description

Participants received cinacalcet daily for 24 weeks in this extension study. For participants who received standard of care (SOC) in parent study 20130356, the starting dose was 0.20 mg/kg/day. For participants who received SOC and cinacalcet in parent study 20130356 or 20110100 the starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events

Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a "yes" or "no" response to the question: Is there a reasonable possibility that the event may have been caused by the study drug?

Secondary Outcome Measures

Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15

This endpoint was analyzed in participants who received SOC only in parent study 20130356. Participants who had no iPTH values during weeks 11 or 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded.

Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28

This endpoint was analyzed in participants who received SOC only in parent study 20130356. For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.

Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28

This endpoint was analyzed in participants who received SOC only in parent study 20130356. For participants who had no values during week 23 and week 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.

Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28

For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.

Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28

For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.

Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28

Serum Corrected Calcium at Baseline, Week 11, and Week 28

Data collected more than 7 days after the last dose of study drug were excluded.

Serum Phosphorus at Baseline, Week 11, and Week 28

Data collected more than 7 days after the last dose of study drug were excluded.

Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15

Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28

The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356. For participants who did not have an iPTH value during weeks 23 and 28, the mean of the last two available post-baseline values collected at protocol-specified visits was used. If only one post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.

Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time

Percent change in iPTH measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded.

Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time

Change in corrected calcium measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded.

Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time

Change in phosphorus measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded.

Full Information

NCT ID

NCT02341417

First Posted

December 2, 2014

Last Updated

June 12, 2020

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02341417

Brief Title

Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

Official Title

A Multicenter Single-arm Extension Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

June 10, 2015 (Actual)

Primary Completion Date

March 15, 2017 (Actual)

Study Completion Date

March 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.

Detailed Description

This extension study was designed to characterize the long-term safety and tolerability of cinacalcet in pediatric patients from Amgen Studies 20130356 (NCT02138838) and 20110100 (NCT01439867) who either had completed the parent study or were ongoing at the time an administrative decision was made to end the parent study. After enrolling into this study participants were administered cinacalcet for 28 weeks or until the time of renal transplant or parathyroidectomy, whichever occurred first. The treatment period was followed by a 4-week safety follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Secondary Hyperparathyroidism, Chronic Kidney Disease

Keywords

Chronic Kidney Disease, Dialysis, Secondary Hyperparathyroidism, Pediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cinacalcet

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cinacalcet

Other Intervention Name(s)

Cinacalcet hydrochloride, Cinacalcet HCL, Sensipar®, Mimpara®

Intervention Description

Cinacalcet was provided as 5 mg capsules for sprinkling or as 30 mg film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

Time Frame

From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15

Description

Time Frame

Baseline (defined as the mean values of samples collected during the screening period and day 1 pre-dose in the extension study) and weeks 11 and 15

Title

Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28

Description

Time Frame

Extension study baseline and weeks 23 and 28

Title

Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28

Description

Time Frame

Extension study baseline and weeks 23 and 28

Title

Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28

Description

Time Frame

Weeks 23 and 28

Title

Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28

Description

Time Frame

Extension study baseline and weeks 23 and 28

Title

Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28

Description

Time Frame

Extension study baseline and weeks 23 and 28

Title

Serum Corrected Calcium at Baseline, Week 11, and Week 28

Description

Data collected more than 7 days after the last dose of study drug were excluded.

Time Frame

Extension study baseline, week 11 and week 28

Title

Serum Phosphorus at Baseline, Week 11, and Week 28

Description

Data collected more than 7 days after the last dose of study drug were excluded.

Time Frame

Extension study baseline, week 11 and week 28

Title

Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15

Description

Time Frame

Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment.

Title

Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28

Description

Time Frame

Baseline and weeks 23 and 28, relative to day 1 of cinacalcet treatment.

Title

Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time

Description

Time Frame

Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).

Title

Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time

Description

Time Frame

Title

Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time

Description

Time Frame

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: All subjects: Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any Study 20140159 activities/procedures being initiated. Dialysate calcium concentration ≥ 2.5 mEq/L at day 1 All subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and screening for Study 20140159: Subjects on anti-convulsant medication must be on a stable dose All subjects from 20130356: Completed treatment through week 20 in the 20130356 study or on study at the time of Study 20130356 termination Dry weight ≥ 12.5 kg at day 1 of Study 20140159 Subjects Randomized to the 20130356 Standard of Care Arm Only: intact parathyroid hormone (iPTH) value ≥ 300 pg/mL (within 7 days of day 1 in Study 20140159) Corrected calcium value ≥ 8.8 mg/dL within 7 days of day 1 in Study 20140159 All Subjects from 20110100: Completed week 26 End of Study visit in the, 20110100 study or on study at the time of Study 20110100 termination Dry weight ≥ 7 kg at day 1 of Study 20140159 EXCLUSION CRITERIA: General (studies 20130356 and 20110100): Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s), other than Amgen Studies 20130356 or 20110100. Other investigational procedures while participating in this study are excluded. Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. Subject has known sensitivity to any of the products to be administered during dosing. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary [ediary]) to the best of the subject and investigator's knowledge History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. Subject previously has entered this study. If sexually active, subject is not willing to use acceptable contraception during treatment and for at least 9 days after the end of treatment. Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias, or other conditions associated with prolonged QT interval A new onset of seizures or worsening of pre-existing seizure disorder All Subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and the screening visit in Study 20140159 will have the following exclusion criteria applied during screening and day 1: Unstable chronic heart failure defined as worsening pulmonary edema or other signs and symptoms as per investigator assessment during screening Received therapy with commercial cinacalcet after the last study visit in Study 20130356 or Study 20110100 before day 1 of Study 20140159 Scheduled date for kidney transplantation from a known living donor that makes completion of the study unlikely Either new or recurrent cardiac ventricular arrhythmias requiring a change in treatment within 10 days prior to screening visit or day 1 of Study 20140159 screening Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase [AST] ≥ 1.5 × upper limit of normal [ULN] OR alanine aminotransferase [ALT] ≥ 1.5 × ULN OR total bilirubin ≥ 1 × ULN per institutional laboratory range) during screening All Subjects - Day 1 Study Visit: Subject has an ongoing adverse event from Studies 20130356 or 20110100 that is considered related to investigational product and is ≥ Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0) grade 3, and/or considered clinically significant in the opinion of the investigator Central laboratory values were not obtained/are not available at day 1 in Study 20140159 Corrected QT Interval (QTc) > 500 ms, using Bazett's formula QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist Use of grapefruit juice, herbal medications, CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole), or CYP2D6 substrates (eg, flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine) Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Facility Name

Research Site

City

Tucker

State/Province

Georgia

ZIP/Postal Code

30084

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Research Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55454

Country

United States

Facility Name

Research Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Research Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Research Site

City

West Orange

State/Province

New Jersey

ZIP/Postal Code

07052

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Research Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84113

Country

United States

Facility Name

Research Site

City

Bruxelles

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Research Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Research Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Research Site

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Research Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Research Site

City

Genova

ZIP/Postal Code

16147

Country

Italy

Facility Name

Research Site

City

Krakow

ZIP/Postal Code

30-663

Country

Poland

Facility Name

Research Site

City

Lodz

ZIP/Postal Code

93-338

Country

Poland

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

107014

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

198205

Country

Russian Federation

Facility Name

Research Site

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

01135

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

32367309

Citation

Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.

Results Reference

background

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

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Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

Secondary Hyperparathyroidism, Chronic Kidney Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial