StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation

NCT ID: NCT06589947

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2029-03-31

Brief Summary

Cardiovascular (CV) disease is a major morbidity in children after kidney transplantation (KTx), limiting life expectancy and impairing graft function. Arterial hypertension (AH) is the dominant CV risk factor, and highly abundant in this patient group. AH can cause left ventricular hypertrophy (LVH), which is predictive of CV death. LVH can be non-invasively assessed by measuring left ventricular mass index (LVMI). Analyses of observational data showed that blood pressure (BP) levels <75th percentile (pct) were associated with a significant reduction of LVMI. Guidelines give BP goals for children with chronic kidney disease (CKD). No guidelines, however, exist on the treatment of AH in pediatric KTx patients. In the proposed multicenter, randomized, parallel group trial with blinded endpoint evaluation we aim to assess n=500 pediatric patients >12 months after KTx at several KTx centers. Patients will be randomly assigned 1:1 to an intensified BP management group (BP target ≤60th pct) and a standard BP management group (BP target <90th pct). The primary endpoint is LVMI after 24 months. Secondary endpoints are estimated glomerular filtration rate (eGFR), pulse wave velocity (PWV) and intima media thickness (IMT) after 24 months. BP control will be guaranteed for both groups through BP telemonitoring, which will be transmitted in real time to the treating physician and the trial's centralized BP office. By defining the adequate BP goal, the results of the proposed study will have direct implications for the care of children after KTx. The results will define an important element of post-KTx care and help to lower CV morbidity and subsequently CV mortality of pediatric KTx patients.

Conditions

Arterial Hypertension; Kidney Transplant; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard BP group

The treatment goal for the standard group is to achieve BP levels \<90th pct.

Group Type: ACTIVE_COMPARATOR

Standard Treatment

Intervention Type: OTHER

Standard treatment is to achieve BP levels \&lt;90th pct.

Intensified BP group

Treatment goal in the intensified group will be lowering BP ≤60th pct.

Group Type: EXPERIMENTAL

Intensified BP control

Intervention Type: OTHER

Treatment goal in the intensified group will be lowering BP ≤60th pct.

Interventions

Intensified BP control

Treatment goal in the intensified group will be lowering BP ≤60th pct.

Intervention Type: OTHER

Standard Treatment

Standard treatment is to achieve BP levels \&lt;90th pct.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Kidney transplantation &gt;12 months ago
• Arterial hypertension

Exclusion Criteria

• Cardiac malformation
• Treatment for a rejection episode within three months prior to inclusion

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg; University of Heidelberg

UNKNOWN

Sponsor Role: collaborator

Berlin; Charité

UNKNOWN

Sponsor Role: collaborator

Bonn; Kindernieren-zentrum Bonn

UNKNOWN

Sponsor Role: collaborator

Essen; University Hospital Essen

UNKNOWN

Sponsor Role: collaborator

Frankfurt; Clementine Kinderhospital

UNKNOWN

Sponsor Role: collaborator

Hamburg; University Hospital Hamburg-Eppendorf

UNKNOWN

Sponsor Role: collaborator

Stuttgart; Olgahospital

UNKNOWN

Sponsor Role: collaborator

Ankara; Hacettepe University Hospital

UNKNOWN

Sponsor Role: collaborator

Vienna; University Hospital Vienna

UNKNOWN

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Dr. Anette Melk

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anette Melk, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Central Contacts

Anette Melk, MD PhD

Role: CONTACT

sophocles@mh-hannover.de

+49 511 532 0 ext. 5597

Bernhard MW Schmidt, MD MSc

Role: CONTACT

sophocles@mh-hannover.de

+49 511 532 0 ext. 2329

References

Grabitz C, Memaran N, Sugianto RI, von der Born J, Bukova M, Lehmann E, Konuhov AK, Holzwart D, Grosshennig A, Wuhl E, Schmidt BMW, Melk A. StOPping Hypertension and imprOving Children's Lives after KidnEy TranSplantation (SOPHOCLES): study protocol for a randomized controlled multicenter trial. Trials. 2025 Aug 27;26(1):315. doi: 10.1186/s13063-025-09033-z.

Reference Type: DERIVED

PMID: 40866927 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SOPHOCLES

Identifier Type: -

Identifier Source: org_study_id