Renal and Systemic Vascular Resistance in Chronic Kidney Disease (CKD)

NCT ID: NCT01380717

Last Updated: 2014-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-02-28

Brief Summary

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Patients with reduced kidney function have a higher risk of heart disease and death. Studies have shown that blood vessels in patients with hypertension change with a decrease of lumen size and growth of the vessel wall. By treating patients with antihypertensive certain medication vessel lumen and walls normalize. Treating hypertension in patients with chronic kidney disease slows the progression of kidney function loss.

The aim is to compare different degrees of antihypertensive medication in patients with chronic kidney disease and hypertension will slow the progression of kidney loss.

Detailed Description

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Conditions

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Chronic Kidney Insufficiency Hypertension Vasodilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard treatment

Patients with CKD 3-4, hypertension, treated for 18 months with beta-blocker and if needed ACE-inhibitor or ARB.

Group Type ACTIVE_COMPARATOR

Beta-blocker, ACE-inhibitor

Intervention Type DRUG

Beta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day

Intensive vasodilation

Patients with CKD 3-4 and hypertension, randomized to treatment with calcium channel blocker and if needed ACE-inhibitor or ARB for 18 months

Group Type ACTIVE_COMPARATOR

Calcium Channel Blockers, ACE-Inhibitor

Intervention Type DRUG

Calcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day

Interventions

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Beta-blocker, ACE-inhibitor

Beta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day

Intervention Type DRUG

Calcium Channel Blockers, ACE-Inhibitor

Calcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* eGFR 15-60 ml/min for at least 3 months
* Blood pressure \> 130 mmHg systolic og \>80 mmHg diastolic (patients without antihypertensive treatment or in treatment with Beta-blockers, ACEi, ARBs or CCB not in maximum dosi).
* Blood pressure \< 130 mmHg systolic og \< 80 mmHg diastolic (patients receiving Beta-blockers, ACEi, ARBs og CCB).
* Fertile women using safe contraceptives

Exclusion Criteria

* Ultrasound verified Polycystic Kidney Disease (ADPKD)
* Claustrophobia (MRi scan).
* Contraindications to MRi.
* Pregnancy or wish to become pregnant in the study period.
* Nephrotic syndrome with gross edema.
* Known allergy to any study medication.
* Blood pressure \< 130 mmHg systolic or \< 80 mmHg diastolic without antihypertensive treatment.
* Blood pressure \> 130 mmHg systolic or \> 80 mmHg diastolic and in maximum dosages of all three Beta-blockers, ACEi (ARBs) and CCB.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niels Henrik Buus, DrMedSc

Role: PRINCIPAL_INVESTIGATOR

Department og Renal Medicine, Aarhus University Hospital, Skejby

Locations

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Department of Renal Medicine, Aarhus University Hospital, Skejby

Aarhus N, , Denmark

Site Status

Countries

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Denmark

References

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Svendsen SL, Rousing AQ, Carlsen RK, Khatir D, Jensen D, Hansen NM, Salomo L, Birn H, Buus NH, Leipziger J, Sorensen MV, Berg P. A Urine pH-Ammonium Acid/Base Score and CKD Progression. J Am Soc Nephrol. 2024 Nov 1;35(11):1533-1545. doi: 10.1681/ASN.0000000000000447. Epub 2024 Jul 17.

Reference Type DERIVED
PMID: 39485702 (View on PubMed)

Other Identifiers

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RenVas

Identifier Type: -

Identifier Source: org_study_id

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