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Safety and Efficacy of ACEI in Alport Syndrome Patients With COL4A3/COL4A4/COL4A5 Variants

Primary Purpose

Alport Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ramipril
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alport Syndrome

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: 30-50 Years;
  2. Sex: All;
  3. Alport syndrome patients with variants of COL4A3/COL4A4/COL4A5; hematuria or microalbuminuria; eGFR>90 mL/min/1.73m2;
  4. Patients with microscopic hematuria only;
  5. Patients with microscopic hematuria and microalbuminuria: 30-300mg/24h or urine albumin/creatinine: 30-300mg/g;
  6. No angiotensin converting enzyme inhibitor (ACEI) and other renin-angiotensin system inhibitors (including angiotensin II receptor antagonists, etc.) treatment.

Exclusion Criteria:

  1. With primary or secondary kidney disease, including IgA nephropathy, membranous nephropathy, lupus nephropathy, benign renal arterioles, etc.;
  2. Patients with a history of angioedema;
  3. Hypovolemia or hypotension (systolic blood pressure less than 90mmHg and/or diastolic blood pressure less than 60mmHg);
  4. Pregnant and lactating women;
  5. Patients with bilateral renal artery stenosis or unilateral renal artery stenosis with solitary kidney;
  6. Hyperkalemia, blood potassium>5.5mmol/L;
  7. Severe aortic stenosis, severe mitral stenosis;
  8. Treatment of drug allergy;
  9. Hypertension or other diseases that may require treatment with angiotensin-converting enzyme inhibitors;
  10. Disagree to participate in this research.

Sites / Locations

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Drug: Ramipril The initial dose of ramipril is 2.5 mg /d. The blood pressure, blood potassium and blood creatinine is measured every 1-2 weeks. If the blood pressure is normal, the dose of ramipril is adjusted to 5 mg /d after 2 weeks. If the blood pressure is low, the dose of ramipril is reduced to 1.25 mg /d until the blood pressure becomes normal, otherwise, stop ramipril using. If the blood potassium is high (>5.5mmol/L), the dose of ramipril is reduced to 1.25 mg /d until the blood potassium becomes normal, otherwise, stop ramipril using. If the blood creatinine is higher before therapy (≥30%), the dose of ramipril is reduced to 1.25 mg /d until the blood creatinine becomes normal, otherwise, stop ramipril using.

No angiotensin converting enzyme inhibitor (ACEI) and other renin-angiotensin system inhibitors (including angiotensin II receptor antagonists, etc.) treatment.

Outcomes

Primary Outcome Measures

Disease progression time
a) Patients from no proteinuria to microalbuminuria; b) patients from microalbuminuria to dominant proteinuria.

Secondary Outcome Measures

5-year disease progression rate and eGFR slope
5-year disease progression rate and eGFR slope

Full Information

First Posted
October 27, 2021
Last Updated
November 23, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05133050
Brief Title
Safety and Efficacy of ACEI in Alport Syndrome Patients With COL4A3/COL4A4/COL4A5 Variants
Official Title
Safety and Efficacy of Early Angiotensin-converting Enzyme Inhibition in Patients With Alport Syndrome Carrying Pathogenic Heterozygous COL4A3,COL4A4 or COL4A5 Mutations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Alport syndrome (AS) is the second most common monogenic cause of end-stage renal failure (ESRF). AS is caused by variants in the COL4A3, COL4A4, and COL4A5 genes, which encode for the a3, a4, and a5 chains of type IV collagen. This trial is a prospective, randomized, controlled and multicenter trial. Mainly to assess the safety and efficacy of ramipril in Alport syndrome patients with variants of COL4A3/COL4A4/COL4A5.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alport Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
510 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Drug: Ramipril The initial dose of ramipril is 2.5 mg /d. The blood pressure, blood potassium and blood creatinine is measured every 1-2 weeks. If the blood pressure is normal, the dose of ramipril is adjusted to 5 mg /d after 2 weeks. If the blood pressure is low, the dose of ramipril is reduced to 1.25 mg /d until the blood pressure becomes normal, otherwise, stop ramipril using. If the blood potassium is high (>5.5mmol/L), the dose of ramipril is reduced to 1.25 mg /d until the blood potassium becomes normal, otherwise, stop ramipril using. If the blood creatinine is higher before therapy (≥30%), the dose of ramipril is reduced to 1.25 mg /d until the blood creatinine becomes normal, otherwise, stop ramipril using.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No angiotensin converting enzyme inhibitor (ACEI) and other renin-angiotensin system inhibitors (including angiotensin II receptor antagonists, etc.) treatment.
Intervention Type
Drug
Intervention Name(s)
Ramipril
Intervention Description
We use ACEI: ramipril, in this prospective, randomized, controlled and multicenter clinical trial to access the safety and efficacy in Alport syndrome patients carried COL4A3/COL4A4/COL4A5 variants.
Primary Outcome Measure Information:
Title
Disease progression time
Description
a) Patients from no proteinuria to microalbuminuria; b) patients from microalbuminuria to dominant proteinuria.
Time Frame
Up to 240 weeks
Secondary Outcome Measure Information:
Title
5-year disease progression rate and eGFR slope
Description
5-year disease progression rate and eGFR slope
Time Frame
Up to 240 weeks
Other Pre-specified Outcome Measures:
Title
Number of patients with adverse events
Description
Number of patients with adverse events
Time Frame
Up to 240 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 30-50 Years; Sex: All; Alport syndrome patients with variants of COL4A3/COL4A4/COL4A5; hematuria or microalbuminuria; eGFR>90 mL/min/1.73m2; Patients with microscopic hematuria only; Patients with microscopic hematuria and microalbuminuria: 30-300mg/24h or urine albumin/creatinine: 30-300mg/g; No angiotensin converting enzyme inhibitor (ACEI) and other renin-angiotensin system inhibitors (including angiotensin II receptor antagonists, etc.) treatment. Exclusion Criteria: With primary or secondary kidney disease, including IgA nephropathy, membranous nephropathy, lupus nephropathy, benign renal arterioles, etc.; Patients with a history of angioedema; Hypovolemia or hypotension (systolic blood pressure less than 90mmHg and/or diastolic blood pressure less than 60mmHg); Pregnant and lactating women; Patients with bilateral renal artery stenosis or unilateral renal artery stenosis with solitary kidney; Hyperkalemia, blood potassium>5.5mmol/L; Severe aortic stenosis, severe mitral stenosis; Treatment of drug allergy; Hypertension or other diseases that may require treatment with angiotensin-converting enzyme inhibitors; Disagree to participate in this research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gengru Jiang
Phone
+86-13917983703
Email
jianggeng-ru@hotmail.com
Facility Information:
Facility Name
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gengru Jiang
Phone
+86-13917983703
Email
jianggeng-ru@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of ACEI in Alport Syndrome Patients With COL4A3/COL4A4/COL4A5 Variants

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