Trial Outcomes & Findings for Preventing Sickle Cell Kidney Disease (NCT NCT02373241)

Last Updated: 2024-04-03

Results Overview

Outcome 1a. Document the rate of acceptance (quantitative) and reasons for acceptance/rejection (qualitative) in a randomized trial of trial of losartan for SCD patients with abnormal nocturnal blood pressures. Outcome 1b. Identify the adherence rate to losartan during a randomized three year trial of losartan for SCD patients (n=40) with abnormal nocturnal blood pressure. Outcome 1c. Determine the adherence rate to study procedures among participants enrolled in a three year trial of losartan for SCD patients (n=40) with abnormal nocturnal blood pressure.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

5 yrs

Results posted on

2024-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Blood Pressure Management Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to \<95th percentile Losartan: Standard dosing	Experimental Blood Pressure Management Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to \<75th percentile Losartan: Experimental dosing
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preventing Sickle Cell Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Blood Pressure Management Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to \<95th percentile Losartan: Standard dosing	Experimental Blood Pressure Management n=1 Participants Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to \<75th percentile Losartan: Experimental dosing	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	—	16 years n=7 Participants	16 years n=5 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 yrs

Population: We stopped the RCT as eGFR was determined not to be an accurate measure of GFR in SCD patients

Outcome measures

Outcome measures
Measure	Standard Blood Pressure Management Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to \<95th percentile Losartan: Standard dosing	Experimental Blood Pressure Management n=1 Participants Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to \<75th percentile Losartan: Experimental dosing
Feasibility as Measured by the Number of Patients That Accept Enrollment, Remain Adherent to Losartan, and Remain Adherent to Study Procedures.	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 5 yrs

Population: This study was terminated early so we did not perform analysis of losartan on incident hypertension.

We will prospectively evaluate the incidence of hypertension (Clinic BP in pts \>5yrs and ABPM in pts \>10 yrs) and role of blood and urine biomarkers (pts \>5ys) among participants with HbSS or SB0 thalassemia (expected cohort n=200) over 5 yrs. We identified 20 participants (34%) with incident hypertension but randomized one to the study. The study was terminated as the eGFR was determined not to be a reliable endpoint in pediatric sickle cell.

Outcome measures

Outcome measures
Measure	Standard Blood Pressure Management Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to \<95th percentile Losartan: Standard dosing	Experimental Blood Pressure Management n=1 Participants Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to \<75th percentile Losartan: Experimental dosing
Number of Patients With Incident Hypertension	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 5 years

Population: We did not have any patients randomized to standard blood pressure management

As a feasibility trial, the effect of losartan on lowering nocturnal hypertension will be monitored to identify the difference in nocturnal BP improvement between the two treatment arms, and within group standard deviation of BP

Outcome measures

Outcome measures
Measure	Standard Blood Pressure Management Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to \<95th percentile Losartan: Standard dosing	Experimental Blood Pressure Management n=1 Participants Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to \<75th percentile Losartan: Experimental dosing
Feasibility as Measured by the Number of Patients With Improvement in Nocturnal Blood Pressure While Receiving Losartan.	—	1 Participants

Adverse Events

Standard Blood Pressure Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental Blood Pressure Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Lebensbugrer

University of Alabama at Birmingham

Phone: 2056389285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place