Trial · NCT03806452

SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)

NCT03806452, Phase 2, Completed, Theravia; results first posted 2025-05-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial). Trials, record NCT03806452. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03806452

On this page

Trial

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

Title: SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)
NCT number: NCT03806452
Status: Completed
Phases: Phase 2
Enrollment: 86 participants, actual
Lead sponsor: Theravia
Conditions: Sickle Cell Disease
Interventions: Hydroxycarbamide, Placebo Oral Tablet
First posted: 2019-01-16
Last updated: 2025-05-14
Results first posted: 2025-05-14

Source ClinicalTrials.gov

Registered outcomes29

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

List	Outcome	Time frame	Description
Primary	Number of Patients Achieving at Least a 30% Decrease in ACR Baseline Value	6 months	The primary endpoint of this study is the proportion of patients in the hydroxycarbamide and placebo groups achieving at least a 30% decrease in ACR baseline value at 6 months after treatment initiation. Patients who do not achieve at least a 30% decrease of the ACR baseline value at month 6 will be considered non-responders.
Secondary	Absolute Mean Changes in eGFR Value	6 months
Secondary	Absolute Mean Changes in ACR Value	6 months
Secondary	Proportion of Patients With a Shift From Macroalbuminuria to Microalbuminuria	6 months
Secondary	Proportion of Patients With a Shift From Microalbuminuria to Normoalbuminuria	6 months
Secondary	Proportion of Patients With a Shift From Macroalbuminuria to Normoalbuminuria	6 months
Secondary	Proportion of Patients With a Shift From Microalbuminuria to Macroalbuminuria	6 months
Secondary	Absolute Mean Changes of Systolic Blood Pressure	6 months
Secondary	Absolute Mean Changes of Body Weight	6 months
Secondary	Absolute Mean Changes of Diastolic Blood Pressure	6 months

1 to 10 of 29Source ClinicalTrials.gov

See all 29 registered outcomes

Outcomes29

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients Achieving at Least a 30% Decrease in ACR Baseline Value	6 months	3 patients in the hydroxycarbamide arm and 2 patients in the placebo arm do not have any measure at 6 months and so were not part of this analysis	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Absolute Mean Changes in eGFR Value	6 months		ml/min/1.73m2	MEAN
SECONDARY	Absolute Mean Changes in ACR Value	6 months		mg/mmol	MEAN
SECONDARY	Proportion of Patients With a Shift From Macroalbuminuria to Microalbuminuria	6 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Patients With a Shift From Microalbuminuria to Normoalbuminuria	6 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Patients With a Shift From Macroalbuminuria to Normoalbuminuria	6 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Patients With a Shift From Microalbuminuria to Macroalbuminuria	6 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Absolute Mean Changes of Systolic Blood Pressure	6 months		mmHg	MEAN
SECONDARY	Absolute Mean Changes of Body Weight	6 months		kg	MEAN
SECONDARY	Absolute Mean Changes of Diastolic Blood Pressure	6 months		mmHg	MEAN

1 to 10 of 29Source ClinicalTrials.gov

See all 29 outcomes

Results by group54

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

Outcome	Group	Value	Spread	Units
Number of Patients Achieving at Least a 30% Decrease in ACR Baseline Value	Hydroxycarbamide	18		Participants
Number of Patients Achieving at Least a 30% Decrease in ACR Baseline Value	Placebo	15		Participants
Absolute Mean Changes in eGFR Value	Hydroxycarbamide	3.2	Standard Deviation 18.5	ml/min/1.73m2
Absolute Mean Changes in eGFR Value	Placebo	-1.0	Standard Deviation 13.8	ml/min/1.73m2
Absolute Mean Changes in ACR Value	Hydroxycarbamide	3.5	Standard Error 19.7	mg/mmol
Absolute Mean Changes in ACR Value	Placebo	1.0	Standard Error 13.1	mg/mmol
Proportion of Patients With a Shift From Macroalbuminuria to Microalbuminuria	Hydroxycarbamide	1		Participants
Proportion of Patients With a Shift From Macroalbuminuria to Microalbuminuria	Placebo	2		Participants
Proportion of Patients With a Shift From Microalbuminuria to Normoalbuminuria	Hydroxycarbamide	10		Participants
Proportion of Patients With a Shift From Microalbuminuria to Normoalbuminuria	Placebo	7		Participants

1 to 10 of 54Source ClinicalTrials.gov

See all 54 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Initial Treatment Period	STARTED	Hydroxycarbamide	46
Initial Treatment Period	STARTED	Placebo	40
Initial Treatment Period	COMPLETED	Hydroxycarbamide	44
Initial Treatment Period	COMPLETED	Placebo	38
Initial Treatment Period	NOT COMPLETED	Hydroxycarbamide	2
Initial Treatment Period	NOT COMPLETED	Placebo	2
Responders Extended Treatment Period	STARTED	Hydroxycarbamide	18
Responders Extended Treatment Period	STARTED	Placebo	15
Responders Extended Treatment Period	COMPLETED	Hydroxycarbamide	15
Responders Extended Treatment Period	COMPLETED	Placebo	9

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events52

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	ARTHRALGIA	Musculoskeletal and connective tissue disorders	Hydroxycarbamide	5	46	6
other	ARTHRALGIA	Musculoskeletal and connective tissue disorders	Placebo	6	40	6
other	BACK PAIN	Musculoskeletal and connective tissue disorders	Hydroxycarbamide	3	46	3
other	BACK PAIN	Musculoskeletal and connective tissue disorders	Placebo	3	40	3
other	PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	Hydroxycarbamide	3	46	4
other	PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	Placebo	1	40	1
other	ASTHENIA	General disorders	Hydroxycarbamide	2	46	2
other	ASTHENIA	General disorders	Placebo	5	40	5
other	CHEST PAIN	General disorders	Hydroxycarbamide	1	46	1
other	CHEST PAIN	General disorders	Placebo	4	40	5

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Hydroxycarbamide	0	46
Total, all-cause mortality	Placebo	2	40
Total, other adverse events	Hydroxycarbamide	30	46
Total, other adverse events	Placebo	29	40
Total, serious adverse events	Hydroxycarbamide	5	46
Total, serious adverse events	Placebo	7	40

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

Trial comparisons7

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

Comparison	Source
Hydroxycarbamide vs Placebo: Proportion of Patients With a Shift From Microalbuminuria to Macroalbuminuria	Trial comparisons
Hydroxycarbamide vs Placebo: Proportion of Patients With a Shift From Microalbuminuria to Normoalbuminuria	Trial comparisons
Hydroxycarbamide vs Placebo: Proportion of Patients With a Shift From Macroalbuminuria to Microalbuminuria	Trial comparisons
Hydroxycarbamide vs Placebo: Number of Patients Achieving at Least a 30% Decrease in ACR Baseline Value	Trial comparisons
Hydroxycarbamide vs Placebo: deaths from any cause	Trial comparisons
Hydroxycarbamide vs Placebo: Proportion of Patients With a Shift From Macroalbuminuria to Normoalbuminuria	Trial comparisons
Hydroxycarbamide vs Placebo: serious adverse events	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/NCT03806452

GET https://conductscience.org/api/trials/v1/NCT03806452/registered?page=2

API reference For AI assistants