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

NCT01380717 | Completed Phase 4 DMC

• 1 other identifier: RenVas
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Insufficiency; Hypertension; Vasodilation

Outcome Measures

Primary Outcomes (1)

• Change in glomerular filtration rate between the two treatment arms.

  Measured at baseline and after 18 months of treatment

Secondary Outcomes (1)

• Changes in glomerular filtration rate stratified after changes in pulse wave velocity, renal vascular resistance and forearm minimal resistance at baseline and after 18 months of treatment.

  18 months

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

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

Drug: Beta-blocker, ACE-inhibitor

Intensive vasodilation

ACTIVE COMPARATOR

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

Drug: Calcium Channel Blockers, ACE-Inhibitor

Interventions

Beta-blocker, ACE-inhibitor DRUG

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

Standard treatment

Calcium Channel Blockers, ACE-Inhibitor DRUG

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

Intensive vasodilation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Renal Medicine, Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 39485702 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Aneurysm

Interventions

Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Calcium Channel Blockers

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Protease Inhibitors; Enzyme Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Cardiovascular Agents; Therapeutic Uses

Study Officials

• Niels Henrik Buus, DrMedSc

  Department og Renal Medicine, Aarhus University Hospital, Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 27, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 27, 2014

Record last verified: 2012-09

Locations

DK (1)