Trial · NCT00004563

Scleroderma Lung Disease

NCT00004563, Phase 3, Completed, The University of Texas Health Science Center, Houston; results first posted 2015-03-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Scleroderma Lung Disease. Trials, record NCT00004563. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00004563

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Scleroderma Lung Disease
NCT number: NCT00004563
Status: Completed
Phases: Phase 3
Enrollment: 158 participants, actual
Lead sponsor: The University of Texas Health Science Center, Houston
Conditions: Lung Diseases, Pulmonary Fibrosis, Systemic Scleroderma, Scleroderma, Systemic
Interventions: Cyclophosphamide, Placebo
First posted: 2000-02-10
Last updated: 2015-03-27
Results first posted: 2015-03-06

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Forced Vital Capacity	12 months	The primary end point was the forced vital capacity (FVC, expressed as a percentage of the predicted value) at 12 months, after adjustment for the baseline FVC.
Secondary	Total Lung Capacity	12 months	expressed as a percentage of the predicted value
Secondary	DLCO	12 months	diffusing capacity of the lungs for carbon monoxide

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Forced Vital Capacity	12 months	The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.	% of predicted	MEAN
SECONDARY	Total Lung Capacity	12 months	The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.	% of predicted	MEAN
SECONDARY	DLCO	12 months	The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.	% of predicted	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Forced Vital Capacity	Cylophosphamide	66.6	Standard Error 1.7	% of predicted
Forced Vital Capacity	Placebo	65.6	Standard Error 1.6	% of predicted
Total Lung Capacity	Cylophosphamide	70.5	Standard Error 1.8	% of predicted
Total Lung Capacity	Placebo	64.7	Standard Error 1.9	% of predicted
DLCO	Cylophosphamide	42.8	Standard Error 1.7	% of predicted
DLCO	Placebo	44.3	Standard Error 2.1	% of predicted

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cylophosphamide	79
Overall Study	STARTED	Placebo	79
Overall Study	COMPLETED	Cylophosphamide	54
Overall Study	COMPLETED	Placebo	55
Overall Study	NOT COMPLETED	Cylophosphamide	25
Overall Study	NOT COMPLETED	Placebo	24

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Neutropenia	Blood and lymphatic system disorders	Cylophosphamide	7	79	7
other	Neutropenia	Blood and lymphatic system disorders	Placebo	0	79	0
other	Pneumonia	Respiratory, thoracic and mediastinal disorders	Cylophosphamide	5	79	5
other	Pneumonia	Respiratory, thoracic and mediastinal disorders	Placebo	1	79	1
other	Hematuria	Renal and urinary disorders	Cylophosphamide	9	79	9
other	Hematuria	Renal and urinary disorders	Placebo	3	79	3
other	Leukopenia	Blood and lymphatic system disorders	Cylophosphamide	19	79	19
other	Leukopenia	Blood and lymphatic system disorders	Placebo	0	79	0
serious	Leukopenia with pneumonia	Blood and lymphatic system disorders	Cylophosphamide	1	79	1
serious	Leukopenia with pneumonia	Blood and lymphatic system disorders	Placebo	0	79	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cylophosphamide
Total, all-cause mortality	Placebo
Total, other adverse events	Cylophosphamide	20	79
Total, other adverse events	Placebo	4	79
Total, serious adverse events	Cylophosphamide	5	79
Total, serious adverse events	Placebo	5	79

Source ClinicalTrials.gov

Papers14

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
16790698	RESULT	PubMed
17717203	DERIVED	PubMed
17901414	DERIVED	PubMed
18641099	DERIVED	PubMed
19892673	DERIVED	PubMed
21547897	DERIVED	PubMed
22156609	DERIVED	PubMed
25452309	DERIVED	PubMed
26704522	DERIVED	PubMed
26757749	DERIVED	PubMed

1 to 10 of 14

See all 14 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01HL060839	SCLERODERMA LUNG STUDY	MAYES, MAUREEN MAUREEN	UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	1999 to 2003

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Cylophosphamide vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00004563

GET https://conductscience.org/api/trials/v1/NCT00004563/registered

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